Inclusig (Ponatinib): Drug Safety Communication - Increased Reports Of Serious
Blood Clots In Arteries And Veins
FDA is investigating an increasing frequency of reports of serious and
life-threatening blood clots and severe narrowing of blood vessels (arteries and
veins) of patients taking the leukemia chemotherapy drug Iclusig (ponatinib). Data
from clinical trials and postmarket adverse event reports show that serious adverse
events have occurred in patients treated with Iclusig, including heart attacks
resulting in death, worsening coronary artery disease, stroke, narrowing of large
arteries of the brain, severe narrowing of blood vessels in the extremities, and the
need for urgent surgical procedures to restore blood flow. FDA is actively working
to further evaluate these adverse events and will notify the public when more
information is available.
Iclusig is a prescription medicine used to treat adults diagnosed with
chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML)
or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), who
are no longer benefiting from previous treatment or who did not tolerate
other treatment. At the time of Iclusig’s approval in December 2012, the drug label
contained information about the risks of blood clots in the Boxed Warning and
Warnings and Precautions sections. In clinical trials conducted before approval,
serious arterial blood clots occurred in 8 percent of Iclusig-treated patients, and
blood clots in the veins occurred in 3 percent of Iclusig-treated patients. In the
most recent clinical trial data submitted by the manufacturer to FDA, at least 20
percent of all participants treated with Iclusig have developed blood clots or
narrowing of blood vessels.
Health care professionals should consider for each patient,
whether the benefits of Iclusig treatment are likely to exceed the risks of
treatment. Patients taking Iclusig should seek immediate medical attention if they
experience symptoms suggesting a heart attack such as chest pain or pressure, pain
in their arms, back, neck or jaw, or shortness of breath; or symptoms of a stroke
such as numbness or weakness on one side of the body, trouble talking, severe
headache, or dizziness. FDA is providing this information to patients and health
care professionals while it continues its investigation.

OxyElite Pro: Health Advisory - Acute Hepatitis Illness Cases Linked To Product Use*
The FDA, along with the Centers for Disease Control and Prevention (CDC)
and the Hawaii Department of Health (DOH), are investigating a growing number
of reports of acute non-viral hepatitis in Hawaii. The Hawaii DOH has reported that
24 of these cases share a common link to a dietary supplement product labeled
as OxyElite Pro.
OxyElite Pro is distributed by USPlabs LLC of Dallas, Texas, and is
sold nation-wide through a wide range of distribution channels, including the
internet and retail stores that sell dietary supplements. There have been 29 cases
of acute non-viral hepatitis with an unknown cause identified in the state of
Hawaii. Eleven of the 29 cases have been hospitalized with acute hepatitis, two
cases have received liver transplants and one person has died. CDC is also looking
at other cases of liver injury nationwide that may be related. Symptoms of all types
of hepatitis are similar and can include fever, fatigue, loss of appetite, nausea,
vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint
pain, yellow eyes, and jaundice.
The epidemiological investigation is being conducted by the Hawaii DOH and the CDC.
As part of FDA’s associated investigation, the agency is reviewing the
medical records and histories of patients identified by the Hawaii DOH. The FDA is
also analyzing the composition of product samples that have been collected from some
of these patients. Additionally, the FDA is inspecting the facilities involved in
manufacturing the product and reviewing production and product distribution
records. Because USPlabs LLC has informed FDA that it believes counterfeit versions
of OxyElite Pro are being marketed in the US and have been on the US market for some
time, FDA is also investigating whether counterfeit product is related to any of the
cases of acute hepatitis.
The FDA advises consumers to stop using any dietary supplement
product labeled as OxyElite Pro while the investigation continues. Consumers who
believe they have been harmed by using a dietary supplement should contact their
health care practitioner.

Fabius Anesthesia Machines: Recall - Did Not Pass High Voltage Test Portion Of Final
Production Test
Dräger issued a statement regarding its voluntary recall on specific Fabius
anesthesia machines. Investigations determined that on some power supply units from
a particular batch, the required minimum clearance between an electrical component
and the unit housing was not maintained. In extreme cases, the influence of
mechanical forces, such as movement of the device, for example, may cause a failure
of the automatic ventilation function of the device. If such a fault occurs,
an audible and visual alarm is generated. Manual ventilation using the device is
still possible and all other device functions remained unaffected. To date, there
have been no reported injuries or reported failures due to this issue.
This recall affected 99 Fabius GS Premium, 9 Fabius OS, 43 Fabius
Tiro, and 1 Fabius Tiro D-M anesthesia machines manufactured between February 2013
and May 2013 and distributed in the United States between March 2013 and June
2013. Affected devices were distributed nationally (see firm press release for
information on affected serial numbers by model).
If users of the Fabius anesthesia machines experience such a
failure of the automatic ventilation function, they should switch over to the manual
ventilation mode by pressing the “Man/Spont” key, confirm with the rotary knob,
and start manual ventilation. Additional details concerning switching to manual
ventilation in case of a fault are provided in the Instructions for Use in the
Fault-Cause-Remedy and Ventilator Fail Safe sections. Hospitals are urged to notify
their personnel accordingly.
For questions regarding the operation and/or servicing of affected Dräger anesthesia
machines in the United States, call DrägerService Technical Support at
1-800-543-5047 (press 4 at the prompt) between the hours of 8AM to 8PM EST Monday
through Friday.

Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT):
Recall - Concerns With Instructions For Use, Promotional Claims and FDA Clearance *
Atossa Genetics Inc. initiated a voluntary recall to remove the ForeCYTE
Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) device
from the market. Atossa is removing the ForeCYTE Breast Health Test and the
MASCT device from the market to address FDA concerns about the current instructions
for use (IFU), certain promotional claims used to market these devices, and the need
for FDA clearance for certain changes made to the Nipple Aspirate Fluid (NAF)
specimen collection process identified in the current IFU. To date, Atossa is
unaware of any adverse incidents or injuries associated with the use of the ForeCYTE
Breast Health test and the MASCT device or the processing method currently
identified in the IFU.
The MASCT device has been cleared by the FDA for use as a sample
collection device, with the provision that the fluid collected using this device can
be used to determine and/or differentiate between normal, pre-cancerous, and
cancerous cells. The MASCT device has not been cleared by the FDA for the screening
or diagnosis of breast cancer. In addition, the ForeCYTE Breast Health Test has not
been cleared or approved by the FDA for any indication. This voluntary recall
includes the MASCT System Kit and Patient Sample Kit. The vast majority of these
products (approximately ninety percent) are in inventory with Atossa’s distributors
and the remaining quantities are at customer sites across the United States. See
firm press release for a list of products affected by this recall.
Distributors and customers should contact Atossa at 800-351-3902
to obtain instructions on how to return these products. Customers with questions may
contact the company via telephone at 1-888-219-4629 at any time.

1% Lidocaine HCL Injection By Hospira: Recall - Presence Of Dark Particulate
[Posted 10/04/2013]
Hospira, Inc. announced it has initiated a voluntary nationwide recall of
one lot of 1% Lidocaine HCI Injection, USP, 10 mg/mL, 20 mL Multiple-dose
Fliptop Vial, NDC 0409-4276-01 Lot 25-090-DK (the lot number may be followed by 01
or 02). This action is due to one confirmed customer report of visible
particulate, identified in the primary container, in the form of dark red/black
particles. The particulate was identified as oxidized stainless steel. Depending on
the particle size, if undetected, it could block administration of the drug to the
patient, causing a delay in therapy. Impact to the patient would depend on the time
it would take to obtain a new vial, the condition being treated and the patient’s
status.
The recall is being conducted as a precautionary measure. The root
cause has not been determined and is under investigation. Hospira informed customers
of the issue in a letter dated Sept. 16, 2013. This lot was distributed March 2013
through June 2013.
Anyone with an existing inventory should stop use and
distribution, quarantine the product immediately, and call Stericycle at
1-866-364-8812 between the hours of 8am to 5pm ET, Monday through Friday, to arrange
for the return of the product. Replacement product from other lots is available.

Emergency Cricothyrotomy Kit By H&H Medical Corporation: Recall - Defective Cuff
Balloon On Endotracheal Airway
On August 27, 2013, H&H Medical Corporation initiated a nationwide recall
of 6,619 units of the H&H Emergency Cricothyrotomy Kit. The product has been found
to have the potential for a defective cuff balloon on the provided endotracheal
airway. The cuff balloon may be defective due to a very particular set of
circumstances (a reduction in package density, a higher than average dose of gamma
sterilization, and the occasional slippage of a protective silicon sleeve during
shipping used to shield the cuff balloon at the end of the endotracheal airway). To
date, no injuries or deaths have been reported to H&H or to the FDA.
The product lot number can be identified by a lot number and
manufacture label applied at the top opening of the kit. The recalled version of the
H&H Emergency Cricothyrotomy Kit was produced between August 16, 2012 and July 29,
2013. See firm press release for complete list of lot numbers.
Consumers who have product should stop using the product and
return them to their original place of purchase for immediate credit. Distributors
are instructed to return all recalled items meeting the lot numbers listed below for
return credit or for immediate replacement. Users should quarantine this product
from inventory and return it to the original source of sale for credit or to request
immediate replacement.Consumers with questions may contact H&H Medical Corporation
via telephone at 800-326-5708 between the hours of 8 a.m. and 4:30 p.m. (Eastern
Time Zone)

Metoclopramide Injection And Ondansetron Injection by Hospira: Recall - Glass Strand
Particulates Caused By Glass Supplier
Hospira, Inc. announced it initiated a voluntary nationwide recall of one
lot of Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL)and two lots of
Ondansetron Injection, USP, 4 mg/2 mL, (2 mg/mL). This action is due to a confirmed
vial defect where glass particulate matter (glass strands) were identified as being
affixed to the inside of the vial walls. There is potential for the glass
particulates to dislodge into the solution. To date, Hospira has not received
reports of any adverse events associated with this issue for these lots.
Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL), NDC 0409-3414-01,
Lot 28-104-DK (the lot number may be followed by a 01), is packaged in a 2 mL
single-dose fliptop vial, with an expiration date of October 1, 2014.
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), NDC 0409-4755-03, Lots 29-484-DK
and 29-510-DK (the lot numbers may be followed by a 01) are packaged in a 2 mL
single-dose fliptop vial, with an expiration date of May 1, 2015. Both products are
packaged as 25 units per carton/100 units per case in glass fliptop vials. The
affected lots were distributed nationwide between June 2013 and September 2013 to
wholesalers/distributors, hospitals and pharmacies.
The administration of an injectable with the presence of foreign particulates may
potentially result in local inflammation, thrombophlebitis, and/or low-level
allergic response. Signs and symptoms could include redness, pain, swelling at the
site, fever, shortness of breath, tachycardia, nausea and vomiting. Additionally,
the particulate contaminants could potentially act as an emboli and impede blood
flow causing tissue/organ damage, especially in vulnerable patients such as
those undergoing surgery, immunosuppressed individuals, infants, children and the
elderly, as well as patients with micro or macrovascular disease, such as cardiac
and renal disease, who may be more at risk since their vasculature, and end
organs, are already compromised.
Anyone with an existing inventory should stop use and
distribution, quarantine the product immediately, and call Stericycle at
1-877-497-3125 between the hours of 8am to 5pm ET, Monday through Friday, to arrange
for the return of the product. Replacement product from other lots is available.

Carefusion Avea Ventilator: Recall - Underreporting Of Tidal Volume If used In
Conjunction With Neonatal Hotwire Flow Sensor
CareFusion announced a voluntary recall of AVEA ventilators regarding
barometric pressure sensor compensation when using the neonatal wye hot wire flow
sensor. AVEA ventilators may experience an underreporting of tidal volume if used in
conjunction with the neonatal hotwire flow sensor. The patient may receive a higher
than expected tidal volume. The error is due to lack of barometric pressure sensor
compensation.
While all AVEA ventilators fall under this voluntary recall, hospitals
in locations at high elevations (higher than 5,000 feet above sea level) that are
using the AVEA ventilator in the neonatal patient care setting are at greatest risk
of this error. The level of underreporting between displayed flow and actual flow
increases proportionately with altitude. CareFusion has received five complaints
from a facility that was operating in the neonatal patient care settings and was
located higher than 5,000 feet above sea level. No injuries have been directly
attributed to this issue.
CareFusion advises its customers in locations higher than 5,000
feet above sea level using the AVEA ventilator in neonatal patient care settings
with a wye hot wire flow sensor to take one of the following actions:
* If using the AVEA Comprehensive ventilator, continue the use of the ventilator
using the VarFlex™ single-patient use sensor (CareFusion part number 50000-40038),
and discontinue use of the neonatal hotwire flow sensor until the
software correction has been installed.
* If using the AVEA Standard ventilator, discontinue use in neonatal patient care
settings and contact CareFusion customer support.
* If a hospital is located below 5,000 feet above sea level no action is necessary
at this time.
Customer inquiries related to this action should be addressed to the CareFusion
Customer Support Center at 1-800-562-6018 between the hours of 7:00 am to 4:30 pm
PDT, Monday through Friday.

*UPDATED 09/27/2013.* FDA alerted patients and health care providers that budesonide
solution, used for nasal irrigation, from The Compounding Shop may be contaminated
and should not be used or administered to patients. FDA observed a 1000 mL bottle of
budesonide solution from The Compounding Shop that contained visible, white,
floating material. FDA identified that material as a fungus and is concerned that
contamination may be present in other budesonide solution products from The
Compounding Shop that may currently be on the market.
FDA is alerting health care providers to immediately quarantine any budesonide
solution products from The Compounding Shop, and not administer it to patients.

Tygacil (tigecycline): Drug Safety Communication - Increased Risk of Death
FDA notified health professionals and their medical care organizations of a
new Boxed Warning describing an increased risk of death when intravenous Tygacil is
used for FDA-approved uses as well as for non-approved uses. These changes to the
Tygacil Prescribing Information are based on an additional analysis that was
conducted for FDA-approved uses after FDA issuing a Drug Safety Communication about
this safety concern in September 2010.
This analysis showed a higher risk of death among patients receiving Tygacil
compared to other antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628),
respectively. The adjusted risk difference for death was 0.6% with corresponding 95%
confidence interval (0.0%, 1.2%). In general, the deaths resulted from worsening
infections, complications of infection, or other underlying medical conditions.
Tygacil is FDA-approved to treat complicated skin and skin structure
infections (cSSSI), complicated intra-abdominal infections (cIAI), and
community-acquired bacterial pneumonia (CABP).
Health care professionals should reserve Tygacil for use in
situations when alternative treatments are not suitable.

W.S. Badger Company Daily SPF 30 Kids & Baby Sunscreen Lotion: Recall - Microbial
Contamination
W.S. Badger Co. Inc. notified the public that it is recalling all lots of
its 4-ounce SPF 30 Baby Sunscreen Lotion and one lot of its 4-ounce SPF 30 Kids
Sunscreen Lotion due to microbial contamination. The products were tested and found
to be contaminated with Pseudomonas aeruginosa, Candida parapsilosis and Acremonium
fungi.
The affected lots include the following:
* SPF 30 Baby Sunscreen Lotion 4oz (UPC: 634084490091&634084490114) Lot #’s 3024A,
3057B, 3063A, 3063B, 3132A, 3133A
* SPF 30 Kids Sunscreen Lotion (UPC: 634084490145 & 634084490169) Lot # 3164A
Both sunscreens are sold in the USA & Canada online and at major
retailers as well as independent food co-ops and pharmacies. The product can be
identified by matching the UPC with the Lot code, which can be found on the top
front of the tube crimp.
Consumers who have purchased the Sunscreen Lotion should not use
these products and may return product to the original point of purchase for a full
refund, or contact Badger directly at 1-800-603-6100 between the hours of 8:30-4:30 ET, Monday - Friday.

Arzerra (ofatumumab) and Rituxan (rituximab): Drug Safety Communication - New Boxed
Warning, Recommendations to Decrease Risk of Hepatitis B Reactivation
FDA approved changes to the prescribing information of the
immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan
(rituximab) to add new Boxed Warning information about the risk of reactivation of
hepatitis B virus (HBV) infection. The revised labels also will include additional
recommendations for screening, monitoring, and managing patients on these drugs to
decrease this risk.
In patients with prior HBV infection, HBV reactivation may occur when the body’s
immune system is impaired. HBV reactivation has occurred in patients with prior HBV
exposure who are later treated with drugs classified as CD20-directed cytolytic
antibodies, including Arzerra (ofatumumab) and Rituxan (rituximab). Some cases have
resulted in fulminant hepatitis, hepatic failure, and death.
Arzerra is used to treat chronic lymphocytic leukemia (CLL) in
patients who have further disease after treatment with the anti-cancer drugs
fludarabine and alemtuzumab. Rituxan is used to treat non-Hodgkin’s lymphoma and
CLL. It is also used to treat other medical conditions, including rheumatoid
arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.
To decrease the risk of HBV reactivation, FDA recommends that
health care professionals:
* Screen all patients for HBV infection before starting treatment with Arzerra or
Rituxan by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core
antibody (anti-HBc).
* Consult with hepatitis experts regarding monitoring and use of HBV antiviral
therapy when screening identifies patients at risk of HBV reactivation due to
evidence of prior HBV infection.
* Monitor patients with evidence of prior HBV infection for clinical and
laboratory signs of hepatitis B or HBV reactivation during Arzerra or Rituxan
therapy and for several months thereafter, since reactivations have occurred
several months following completion of therapy with these drugs.
* In patients who develop reactivation of HBV while on Arzerra or Rituxan,
immediately discontinue the drug and start appropriate treatment for HBV. Also
discontinue any chemotherapy the patient is receiving until the HBV infection is
controlled or resolved. Because of insufficient data, no recommendation can be
made regarding the resumption of Arzerra or Rituxan in patients who develop HBV
reactivation hepatitis.
For Patients:
* Before receiving Arzerra or Rituxan, tell your health care professional if you
have or have had any severe infections, including HBV.
* If you have had HBV infection, your health care professional should monitor you
for HBV infection during treatment and for several months after you stop treatment
with Arzerra or Rituxan.

Duragesic (fentanyl) Patches: Drug Safety Communication - Packaging Changes to
Minimize Risk of Accidental Exposure
FDA is requiring color changes to the writing on Duragesic (fentanyl) pain
patches so they can be seen more easily. FDA continues to learn of deaths from
accidental exposure to fentanyl patches.
Patients and health care professionals are reminded that fentanyl patches are
dangerous even after they’ve been used because they still contain high amounts of
strong narcotic pain medicine. Accidental exposure to these patches can cause
serious harm and death in children, pets, and others.
In an effort to minimize the risk of accidental exposure to fentanyl patches, FDA is
requiring the manufacturer of Duragesic to print the name and strength of the drug
on the patch in long-lasting ink, in a color that is clearly visible to patients and
caregivers. The current ink color varies by strength and is not always easy to see.
This change is intended to enable patients and caregivers to more easily find
patches on patients’ bodies and see patches that have fallen off, which children or
pets could accidentally touch or ingest. The manufacturers of generic fentanyl
patches are being requested to make similar changes.
Duragesic (fentanyl) patch is a strong prescription pain medicine that
contains a narcotic opioid. It is marketed under the brand-name Duragesic and also
as generic products.
Patients should be aware that patches that are not stuck to the
skin tightly enough may accidentally fall off a patient and stick to someone in
close contact, such as a child. Used fentanyl patches require proper disposal after
use ― fold the patch, sticky sides together, and flush it down the toilet right
away. See the FDA Drug Safety Communication for additional information, including
recommendations for patients, caregivers, and health professionals, and a data
summary.

Baxter Dual Luer Lock Caps: Class I Recall - Presence of Loose Particulate Matter
Found In Packaging
Baxter International Inc. announced it has initiated a voluntary recall of
two lots of its Dual Luer Lock Caps (Product Code 2C6250, Lots 10043 and 10044)
because of the presence of loose particulate matter found in the packaging.
Particulate matter entering the fluid path from the Luer Lock Caps may result in
thrombotic and embolic events, including: pulmonary embolism, myocardial infarction
and stroke. There have been no reported complaints associated with this issue,
however embolic events may not be easily attributed to such particulate matter. The
root cause has been identified and resolved. FDA has designated this as a Class I
recall.
Baxter's Dual Luer Lock Cap is used as a protective cap on access
ports on medical devices such as stopcocks or IV sets when not in use. Affected lots
were distributed to customers between June 19, 2013, and August 20, 2013.
Customers should not use product from the two recalled lots and
should locate and remove all affected product from their facility. Non-affected lot
numbers can continue to be used according to the instructions for use. Affected lots
should be returned to Baxter for credit by contacting Baxter Healthcare Center for
Service at 1-888-229-0001 between the hours of 7:00 a.m. and 6:00 p.m., Central
Time.

HeartSine Technologies Samaritan 300/300P PAD Public Access Defibrillators: Recall -
Power, Battery Issues
Certain Samaritan 300/300P PAD devices manufactured before December 2010
have been found to intermittently turn on and off, which may eventually deplete the
battery. In addition and separately, certain Samaritan 300/300P PAD devices
containing early versions of the battery management software may misinterpret a
temporary drop in battery voltage as signaling a low battery and subsequently turn
the device off. In certain instances, a device experiencing either condition could
be unable to deliver therapy during a cardiac event.
Samaritan 300/300P PAD devices with the following serial numbers inclusive are
affected by one or both of these issues:
* 0400000501 to 0700032917
* 08A00035000 to 10A00070753
* 10C00200000 to 10C00210106
The potentially affected Samaritan 300/300P PADs were manufactured
from August 2004 to December 2010 and have a warranted life of 7 years. Potentially
affected devices were distributed globally.
If you have a device that is affected by this issue and you HAVE
NOT contacted the company to receive a free upgrade kit, please do so immediately.
Because a device experiencing the on/off issue will function appropriately if it has
an adequate power source, HeartSine is sending affected customers a new PAD-PAK to
be held in reserve and an accompanying hang tag with instructions for when and how
to insert the reserve PAD-PAK so that the customer always has the ability to deliver
therapy in a rescue attempt. In addition, HeartSine is providing a software upgrade
(with a CD, data cable and associated User Manual) to bring all users up to a more
recent version of the software that the company's data shows is no longer
susceptible to the secondary issue. See the firm Press Release for additional
instructions.

Bupivacaine HCL Injection 0.25% (2.5 MG/ML) and Bupivacaine HCL 0.75% (7.5 MG/ML),
30 ML Single-Dose Vials by Hospira, Inc.: Recall- Presence of Particulate Matter*
Hospira, Inc. on July 12, 2013, initiated a voluntary nationwide recall to
the user level for one lot of 0.25% Bupivacaine HCl Injection, USP (2.5 mg/mL), 30
mL Single-dose Vial (NDC 0409-1159-02). An expanded recall was issued on August 29,
2013 for one lot of 0.75 Bupivacaine HCl Injection, USP (7.5 mg/mL), 30 mL
Single-dose Vial (NDC 0409-1165-02). Both recalls are due to confirmed customer
reports of particulate floating and/or embedded in the glass vial. The particulate
was identified as stainless steel ranging in size from 542 microns to 1700 microns
in lot 18-136-DK (0.25% bupivacaine) and as iron oxide with an average size of 2000
microns in lot 23-338-DK (0.75% bupivacaine).
The administration of an injectable with the presence of foreign particulates may
potentially cause thrombophlebitis, bacteremia, sepsis, and/or endocarditis and
death may result. Signs and symptoms could include redness, pain, swelling at the
site, fever, shortness of breath, tachycardia, nausea and vomiting. Depending on the
particle size, if undetected, it could block administration of the diluted drug to
the patient, causing a delay in therapy.
Bupivacaine is indicated for the production of local or regional
anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic
and therapeutic procedures, and for obstetrical procedures.
Both products are packaged 25 units per carton/50 units per case in glass teartop
vials. Lot 18-136-DK was distributed August 2012 through September 2012. Lot
23-338-DK was distributed January 2013 through May 2013. Both lots were distributed
nationwide to wholesalers/distributors, hospitals and pharmacies.
Anyone with an existing inventory should immediately quarantine
any affected product and return the product to Stericycle. For contact information
regarding the return of products or clinical inquiries please see the Firm Press
Release.

Creafuse Powder Grape and Creafuse Powder Fruit Punch: Recall - Contains DMAA
Ge Pharma, LLC is recalling Creafuse Powder Grape Lot# GE4568 and Creafuse
Powder Fruit Punch Lot #GE4570, because they contain 1,3 dimethylamylamine (DMAA).
DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in
dietary supplement products.
The FDA has warned that DMAA is potentially dangerous to health. Ingestion of DMAA
can elevate blood pressure and lead to cardiovascular problems. A number of adverse
effects associated with DMAA containing dietary supplements have been reported to
the FDA. The FDA has also warned that DMAA is not a dietary ingredient and thus, is
not Dietary Supplement Health and Education Act (DSHEA) compliant.
These products were distributed nationwide and was sold via telephone
and email. They are packaged in a white, 600 gram container with an expiration date
of 2/2015.
Consumers who may have purchased the affected lot numbers of
Creafuse should immediately discontinue use of the product and contact their health
care professional if they have experienced any adverse effects. Consumers can
contact GE Pharma LLC at 1-203-675-1057, Monday – Friday,
11 a.m. – 5 p.m. EST to receive further instructions for disposing, returning the
product(s), refunds, credits, exchanges, or with any questions.

Leiter's Compounding Pharmacy: Recall - Concerns of Sterility Assurance
* Bevacizumab Lot No. 08052013@1, expiry 11/03/13
* Bevacizumab Lot No. 08052013@4, expiry 11/03/13
* Lidocaine/phenylephrine Lot No. 07302013@6, expiry 10/28/13
Leiter's Compounding Pharmacy is voluntarily recalling 3 lots of its
sterile products due to concerns of sterility assurance with Front Range
Laboratories, Leiter's Compounding Pharmacy's independent testing laboratory. FDA
investigators observed that methods used by the independent laboratory to assess
sterility may have resulted in pharmacies receiving inaccurate laboratory test
results. The FDA has concerns that results obtained from the laboratory are not
reliable.
The use of a non-sterile injectable product exposes patients to the risk of
contracting serious life-threatening infections.
These products were dispensed to health care providers between 8/05/13
to 9/02/13 nationwide throughout the United States.
Leiter's Compounding Pharmacy is notifying prescribing Physicians
by first class mail, telephone, and/or email and is arranging for return of all
recalled products. Facilities that have product which is being recalled should stop
using and return to Leiter's Compounding Pharmacy.
To return product or request assistance related to this recall, users should contact
Leiter's Compounding Pharmacy at 1-800-292-6772, Monday through Friday, between 8:00
a.m. and 5:00 p.m. PST.

Park Compounding Sterile Medication: Recall – Concerns of Sterility Assurance
Park Compounding is voluntarily recalling one lot of sterile medication
Testoserone Cypionate (Sesame Oil) 200mg/ml Lot #05072013@1 Exp: 11/3/2013 for
injection in 10ml amber vials, to the consumer level. In a recent inspection, FDA
investigators observed that methods used by Front Range Laboratories to assess
sterility may have resulted in pharmacies receiving inaccurate laboratory test
results. FDA has concerns that results obtained from the laboratory are not
reliable. If there is microbial contamination in products intended to be sterile,
patients are at risk of serious infections which may be life threatening.
The prescription preparations were sold during May and June of 2013,
in the following states: California and Indiana. The products would have been sold
directly to customers (pick up and by mail) and to physician offices by prescription
(pick up and by mail).
Customers that have product which is being recalled should stop
using it and contact Park Compounding to arrange for return of unused product.
Customers with questions regarding this recall can contact Park Compounding Center
at 949-551-7195 Monday through Friday, 9am to 5pm PST.
Customers should contact their physician or healthcare provider if they have
experienced any problems that may be related to taking or using these preparations.

Avella Specialty Pharmacy Sterile Medications: Recall - Concerns Of Sterility
Assurance At Testing Vendor
Avella Specialty Pharmacy is voluntarily recalling two compounded sterile
medications, Bevacizumab 1.25 mg/0.05 mL PF and Vancomycin PF (BSS) 1%. The recall
is a result of concerns of sterility assurance with the specialty pharmacy’s
independent testing laboratory, Front Range Laboratories. To date, Avella has not
received any reports of adverse events related to the recall.
Avella was notified that in a recent inspection of Front Range Labs,
FDA investigators observed methods used to assess sterility and other qualities
(e.g. strength and stability) which may have resulted in Avella receiving inaccurate
laboratory test results on the specified lots. FDA has raised concerns that test
results obtained from Front Range Labs may not be reliable. Therefore, Avella
decided to conduct this voluntary recall out of an abundance of caution. The
recalled products were dispensed directly to healthcare providers nationwide and the
medications can be identified based on product label and corresponding medication
name and lot number (see firm press release for lot numbers).
Patients should contact their physician or healthcare provider if
they have experienced any problems that may be related to taking or using this
drug product. Patients and healthcare providers with questions regarding this recall
can contact Avella at (877) 738-0797 Monday through Friday between 6am and 6pm.

MOTRIN Infants Drops Original Berry Flavor 1/2 fl oz: Recall - Particles Identified
McNeil Consumer Healthcare is voluntarily recalling at the retail level
three lots, approximately 200,000 bottles, of Concentrated MOTRIN Infants’ Drops
Original Berry Flavor 1/2 fl oz bottles distributed in the United States (refer to
Firm Press Release for full product list).
After releasing these three lots of Concentrated MOTRIN Infants’ Drops Original
Berry Flavor 1/2 fl oz into the market, tiny plastic particles (approximately 1 mm
in size or about the size of a poppy seed) were identified in a different product
lot during manufacturing. This lot was not released to the market. It was determined
that the particles originated in a shipment from a third party supplier of
ibuprofen, the active ingredient in Concentrated MOTRIN Infants’ Drops Original
Berry Flavor 1/2 fl oz. Out of an abundance of caution, McNeil is voluntarily
recalling the three lots released to the market made with the same batch of active
ingredient.
Concentrated Infants’ MOTRIN Drops Dye-Free Berry Flavor 1 fl oz is
not included in this recall. Children’s or Adult MOTRIN products are not included in
this recall.
McNeil is asking retailers to remove the affected lots from store
shelves, and is asking consumers to stop using and dispose of any product they may
have that is included in this recall.

University Compounding Pharmacy Injection Products: Recall - Lack of Sterility
Assurance
University Compounding Pharmacy is voluntarily recalling products,
including Testosterone Cypionate (Sesame Oil), Testosterone Cypionate/Testosterone
Proprionate, and PGE-1 NS, for injection, to the consumer level (refer to Recall
Notice for a detailed product list with affected lot numbers and expiry dates). In
a recent inspection, FDA investigators observed that methods used by the Independent
Third Party laboratory to assess sterility may have resulted in pharmacies receiving
inaccurate laboratory test results. FDA has concerns that results obtained from the
laboratory are not reliable. If there is microbial contamination in products
intended to be sterile, patients are at risk of serious infections which may be life
threatening.
The prescription preparations were distributed nationwide from May
9th, 2013 to September 7th, 2013.The preparations would have been sold, directly to
customers by pick up and by mail.
Customers that have product which is being recalled should stop
using it and contact University Compounding Pharmacy to arrange for return of unused
product. Customers with questions regarding this recall can contact University
Compounding Pharmacy at 1875 Third Ave, San Diego CA 92101 619-683-2005.
Customers should contact their physician or healthcare provider if they have
experienced any problems that may be related to taking or using these preparations.

Medaus Pharmacy Sterile Compounded Products - Recall: Inability to Confirm Sterility
Medaus Pharmacy is voluntarily recalling certain sterile compounded
consumer products (see table in press release) due to inability to confirm that the
quality control testing performed on these specific lots by an independent, third
party laboratory was conducted in a manner consistent with standards.
The use of a non-sterile injectable product exposes patients to the
risk of contracting serious life-threatening infections. Medaus has not received any
reports of adverse events related to the products affected by this recall to date.
Medaus is notifying its customers by telephone and email, and is
arranging for return of affected products. Health care facilities and customers that
have products which are being recalled should stop using the product and call Medaus
at 800-526-9183 for instructions on returning the product for a full refund. To
return medication or request assistance related to this recall, patients and
physicians should contact Medaus Pharmacy at (800) 526-9183 , Monday through Friday,
between 9 a.m. and 5 p.m. CDT.

Siemens MicroScan Synergies Plus And MicroScan RapID/S Plus Negative Panels: Class I
Recall - False Susceptible And False Intermediate Results
MicroScan Synergies plus and MicroScan RapID/S plus Negative Panels are
reporting false susceptible and false intermediate results for imipenem and
meropenem antimicrobial susceptibility testing when using the MicroScan WalkAway
System. This defect may lead to treatment with an inappropriate antibiotic or a
delay in initiating appropriate therapy.
This recall covers 78,020 panels distributed in the US between
07/11/2011 and 08/02/2013. See the Recall Notice below for a listing of affected
part numbers.
Siemens sent an Urgent Field Safety Notice dated August 21, 2013,
to all affected customers. The letter identified the defective products, problem and
actions to be taken. The letter instructed customers to suppress all reporting of
sensitive and intermediate results for imipenem and meropenem. Siemens also
recommends that customers consider the need to review previous test results, conduct
patient follow-up, and/or repeat testing. In addition, an Important Product
Information notice will be added to products manufactured in future kits.

Cubicin (daptomycin for injection): Recall - Glass Particulate Matter Present in
Four Lots*
Cubist has notified customers by letter and phone of the voluntary recall
of four lots of Cubicin (daptomycin for injection) due to the presence of
particulate matter found in a number of vials from four lots shipped from May 2011
to March 2013.
The administration of glass particulate, if present in an intravenous
drug, poses a potential safety risk to patients. Case reports suggest that sequelae
of thromboembolism, some life-threatening (such as pulmonary emboli), may occur.
Patients with preexisting condition of trauma or other medical condition that
adversely affects the microvascular blood supply are at an increased risk.
Administration of a glass particulate can also lead to formation of granulomas,
which represent a protective local inflammatory response to the foreign material and
are typically non-serious.
Anyone with an existing inventory of the product lots listed in
the firm's press release should determine whether they have product from the
recalled lots, quarantine and discontinue distribution of all recalled lots of the
product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EST,
Monday through Friday, to arrange for return and replacement of affected lots.
For healthcare professionals and pharmacists with questions regarding this recall
may contact Cubist Medical Information at (877) 282-4786 between the hours of 8 a.m.
to 5:30 p.m. EST, Monday through Friday.

Gilenya (fingolimod) - Drug Safety Communication: Investigating Rare Brain Infection
FDA is alerting the public that a patient in Europe diagnosed with possible
multiple sclerosis (MS) has developed a rare and serious brain infection after
taking the drug Gilenya (fingolimod). This is the first case of progressive
multifocal leukoencephalopathy (PML), reported following the administration of
Gilenya to a patient who had not previously received Tysabri (natalizumab), an MS
drug associated with a higher risk of PML.
PML is a rare and serious brain infection caused by the John
Cunningham (JC) virus that damages the fatty covering of the brain called myelin.
PML usually causes death or severe disability. Gilenya is used to treat relapsing
forms of MS, a nervous system disease that affects the brain and spinal cord.
Novartis reports that approximately 71,000 patients worldwide have been treated with
Gilenya.
Patients should not stop taking Gilenya without first discussing
any questions or concerns with their health care professionals. FDA is providing
this alert while continuing to investigate the PML case, and is working with
Gilenya’s manufacturer, Novartis, to obtain and review all available information
about this occurrence. FDA will communicate its final conclusions and
recommendations after the evaluation is complete.

Stryker Spine: Class 1 Recall - OASYS Midline Occiput Plate
FDA and Stryker notified healthcare professionals of a class 1 recall due
to reports of fracture of the pin that connects the implant's tulip head to the
plate body. This may cause serious adverse health consequences including blood loss,
nerve injury, and the need for revision surgery to replace the fractured implant.
On May 30, 2013, Stryker issued an Urgent Medical Device Recall
requesting medical facilities to examine their inventory and immediately stop
distributing or using the recalled lots. If a medical facility has the affected
product in stock, it should be returned to Stryker.
On June 20, 2013, Stryker notified spinal implant surgeons recommending routine
clinical and radiographic post-operative evaluation for patients with an implanted
OASYS Midline plate.
If a patient begins experiencing symptoms including pain,
weakness, or numbness, urgent evaluation is needed. For patients who have had a
revision surgery, Stryker recommends routine post-operative care and follow-up.

Wellness Pharmacy, Inc. Products: Recall - Laboratory Results Indicating Microbial
Contamination
Wellness Pharmacy, Inc. issues nationwide voluntary recall of certain
sterile products due to laboratory results indicating microbial contamination. If
there is microbial contamination in medications intended to be sterile,patients are
at risk of serious infections which may be life threatening. To date Wellness
Pharmacy has not received any reports of adverse events related to this recall.
This recall was initiated after Wellness Pharmacy was notified that in
a recent inspection of Front Range Labs, FDA investigators observed methods used by
Front Range Labs to assess sterility and other qualities (e.g.,strength and
stability) may have resulted in Wellness Pharmacy receiving inaccurate sterility
test results on following products: Dexpanthenol 250 mg/mL, Magnesium Sulfate 50%,
Methylcobalamin 1 mg/mL, Sodium Phenylbutyrate 200 mg/mL,R.L. Glutathione 100 mg/mL,
and Ascorbic Acid (cassava) 500 mg/mL (see firm press release for lot numbers).
Recalled medications were distributed to individual patients and to physician
offices nationwide. These liquid medications are ineither clear or amber sterile
vials ranging in size from 1ml to 50ml. The medications can be identified by the
label on each vial, which will have the name of the drug, strength or concentration,
lot number, use by date, and vial size.
To return medication or request assistance related to this recall,
patients and physicians should contact Wellness Pharmacy at 205-879-6551 or
800-227-2627, Monday through Friday, between 9 a.m. and 4 p.m. CDT. Patients should
contact their physician or health care provider if they have experienced any
problems that may be related to taking these medications.

JCB Laboratories Products: Recall - Sterility Assurance at Testing Vendor
JCB Laboratories (JCB) is issuing a recall of six lots of sterile drug
products to the user level due to concerns of sterility assurance following a recent
inspection by FDA of Front Range Laboratories of Loveland, Colorado, one of the
contract testing labs used by JCB. If there is microbial contamination in products
intended to be sterile, patients are at risk for serious, potentially
life-threatening infections.
The following JCB Laboratories compounded products are subject to the
recall: Sodium thiosulfate, 25% (250 mg/mL), Sodium citrate, 4% solution for
injection, Sodium citrate, 4% with gentamicin 320 mcg/mL solution for injection, and
Acetylcysteine, 20% solution for inhalation *(see firm press release for lot
numbers)*. The recalled products were distributed to outpatient dialysis clinics in
multiple states from July 8, 2013, through Aug. 20, 2013. JCB has not received any
reports of adverse events related to this recall to date. In the recent inspection
of Front Range Labs, the FDA stated it observed that methods used by Front Range to
assess sterility and other qualities (e.g., strength and stability) may have
resulted in pharmacies receiving inaccurate laboratory test results.
Consumers should contact their physician or health care provider
if they have experienced any problems that may be related to taking or using this
drug product. JCB has begun notifying its customers by telephone, email, fax and
mail. To return product or request assistance related to this recall, users should
contact JCB Laboratories at 316-773-0405, Monday through Friday, between 8:00 a.m.
and 5:00 p.m. CDT.

Compounded Sterile Preparations By Park Pharmacy & Compounding Center: Recall - Lack
of Sterility Assurance
Park Pharmacy & Compounding Center is voluntarily recalling two lots of
products Methylcobalamin 5mg/ml 30ml Amber Vials Lot #06132013@1 Exp: 12/10/2013 and
Multitrace-5 Concentrate 10ml Amber Vials Lot #05212013@20 Exp: 11/17/2013 for
injection, to the consumer level. In a recent inspection, FDA investigators observed
that methods used by the laboratory to assess sterility may have resulted in
pharmacies receiving inaccurate laboratory test results. FDA has concerns that
results obtained from the laboratory are not reliable.
The prescription preparations were sold during June and July of 2013,
in California, Florida, New Mexico and Indiana. The products would have been sold
directly to customers (pick up and by mail) and to physician offices by prescription
(pick up and by mail).
Customers with questions regarding this recall can contact Park
Pharmacy & Compounding Center at 949-551-7195 Monday through
Friday, 9am to 5pm PST. Customers should contact their physician or healthcare
provider if they have experienced any problems that may be related to taking or
using these preparations. Park Pharmacy & Compounding Center is notifying its
customers by phone and mail and is arranging for return of all recalled product
lots. Customers that have product which is being recalled should stop using it and
contact Park Compounding to arrange for return of unused product.

Ortiga: Public Notification - Contains Hidden Drug Ingredient
The Food and Drug Administration (FDA) is advising consumers not to
purchase or use Ortiga, an unapproved product promoted for a variety of health
conditions and sold on multiple websites, including Ebay, and in some retail
stores. The product is manufactured in Mexico and labeled primarily in Spanish.
FDA laboratory analysis confirmed that Ortiga contains the
prescription drug ingredient, diclofenac. Diclofenac is a non-steroidal
anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDs may cause increased
risk of cardiovascular events, such as heart attack and stroke, as well as serious
gastrointestinal damage, including bleeding, ulceration, and fatal perforation of
the stomach and intestines. This hidden drug ingredient may also interact with
other medications and significantly increase the risk of adverse events,
particularly when consumers use multiple NSAID-containing products.
Consumers should stop using this product immediately and dispose
of it. Consumers should consult a health care professional as soon as possible if
they have experienced any negative side effects, such as unusually dark stools or
urine, stomach pain, increased bruising, or other signs of bleeding.

Covidien Monoject Prefill Flush Syringes: Recall - Not Subjected To AutoClave
Sterilization Process Or Mismatched Syringe Tip Cap, Syringe Label, Filled Volume
And Wrapper
Covidien announced that it has initiated a voluntary recall of certain lots
of Monoject prefill flush syringes. This recall is being conducted due to the risk
that a number of the syringes were filled with water but not subjected to the
autoclave sterilization process. These products are labeled as either sodium
chloride flush or heparin lock flush. Some of these syringes have the mismatched
syringe tip cap, syringe label, filled volume and wrapper. However, for the sodium
chloride flush syringes with matched tip cap, syringe label, filled volume and
wrapper, there are no visual cues for the clinician to identify the problematic
products. If non-sterile fluid is administered there is a health risk of
life-threatening infection to the blood stream or other areas. Also if the clinician
uses the heparin lock flush syringe containing only water on peripheral or venous
catheters, the patency of the intravascular device may not be maintained and
clotting may occur. This could result in non-functional intravenous access requiring
the device to be replaced.
Only Monoject prefill flush syringes from the lot numbers listed are
affected by this action (see Firm Press Release for list of affected lot numbers).
The lot numbers can be found on the shipper case, carton and individual syringes.
Customers are required to identify, segregate and return any affected products in
their inventory.
Customers have been notified of this issue by letter dated August
16, 2013. To return the affected product for credit, please contact our Customer
Service group at 1-800-962-9888.

Aidapak Services LLC, is conducting a voluntary recall of
specific unit
dose repackaged products sent to 25 hospital inpatient
pharmacies in the States of
Washington, Oregon, California, and Arizona for products listed
on the company’s
website. The Firm voluntarily recalled these products to the
hospital/user level
after learning of possible incorrect labeling which could
involve OTC, prescription,
and dietary supplement products.

Some of the products, if incorrectly labeled, could result in
patients receiving
drugs that were not prescribed, which could result in allergic
reactions or other
undesired effects. Pregnant women could receive a drug
that they should not take
or, as a result of receiving an incorrect medication, patients
may not receive
proper treatment of their disease or condition. This may pose
serious or
life-threatening risk to a patient’s health.

AidaPak shipped affected products to four states only:
Washington,
Oregon, California, and Arizona. Products affected by this
recall are limited to
strip packs packaged between May 1, 2013 and July 1, 2013,
single-use dosage form,
intended specifically to be administered to hospital patients
while admitted to the
hospital. All products affected by this recall are stamped with
AidaPak’s packaging
stamp.

The potentially affected hospitals, Emergency Rooms, and clinics
should stop distributing immediately and quarantine the
products. Hospitals that may
have sent product to other hospital pharmacies or clinics should
contact them and
make them aware of the recall. If you dispense medication to
patients being
discharged on an outpatient basis, please contact those patients
who may have
received the impacted products. Patients who were given
prescriptions by a
hospital’s outpatient pharmacy to be taken home should check
the name and pedigree
number against the recalled list provided in the Firm Press
Release.

Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly
permanent nerve damage
FDA has required the drug labels and Medication Guides for all
fluoroquinolone antibacterial drugs be updated to better describe the serious side
effect of peripheral neuropathy. This serious nerve damage potentially caused by
fluoroquinolones may occur soon after these drugs are taken and may be permanent.
The risk of peripheral neuropathy occurs only with fluoroquinolones
that are taken by mouth or by injection. Approved fluoroquinolone drugs include
levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin
(Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive). The topical formulations
of fluoroquinolones, applied to the ears or eyes, are not known to be associated
with this risk.
Make sure your patients know to contact you if they develop
symptoms of peripheral neuropathy. Make sure your patients receive the Medication
Guide with every prescription. If a patient develops symptoms of peripheral
neuropathy, the fluoroquinolone should be stopped, and the patient should be
switched to another, non-fluoroquinolone antibacterial drug, unless the benefit of
continued treatment with a fluoroquinolone outweighs the risk.

Hospira Blood Sets: Recall - Instances Of Outer Wall Of Blood Bags Punctured With
Piercing Pin
Hospira, Inc. announced a recall of certain blood sets. There have been
reports from customers of instances in which the outer wall of blood bags were
punctured with the piercing pin on certain Hospira blood sets during insertion of
the pin into the blood bag. If the piercing pin on this product punctures the outer
wall of a blood bag, it may result in spillage of the blood and blood products
stored in the bag, resulting in a delay/interruption in therapy. Delay/interruption
in therapy can potentially lead to significant injury or death. This issue has been
identified as a contributing factor in one report of a patient death due to a
delay/interruption in therapy.
The impacted list numbers are: 14200-04-28 Secondary Blood Set; 14203-04-28 Blood
Set; 14206-04-28 Y-type Blood Set; 14207-04-28 Blood Set; 14210-04-28 Plum™ Blood
Set; 14211-04-28 Plum Blood Set; 14212-04-28 Plum y-type Blood Set, 14217-04-28
y-type Blood Set and 14219-04-28 Y-type Blood Set. These sets were distributed July
2011 through February 2013.
The root cause of the punctures has been identified as the design of the new
International Organization for Standardization (ISO)-compliant pin, which has a
sharp point that can sometimes pierce the wall of non-ISO-compliant blood bags.
Hospira blood sets are used for the administration of blood and blood
products. Hospira distributed an Important Safety Information Letter to customers
regarding this issue in April 2013.
At this time, there is no need for customers to discontinue use of
or return Hospira blood sets. However, Hospira recommends users exercise extreme
caution when piercing blood bags with a Hospira blood set mentioned above and make
sure that all instructions for use included with the blood bag and facility’s
protocol for spiking blood bags are completely followed in order to minimize the
possibility of puncturing the outer wall of the blood bag. Hospira has begun
distribution of sets with a blunter piercing pin that is shorter than the pins in
the Impacted List Numbers which came available in March 2013. Customers should
contact Hospira or their local representative for information about these sets.

Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose
Error Reduction System (DERS) Drug Library Kit: Class I Recall - Potential for
Incorrect Recommended Infusion Rate
Biomedical Engineering, Nursing, Radiology, Risk Manager
FDA notified healthcare professionals of a Class I recall of the Iradimed
Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error
Reduction System (DERS) Drug Library Kit. The Dose Error Reduction System (DERS) can
potentially give an incorrect recommended value for the pump infusion rate during
the initial infusion setup. This is due to a specific key sequence when the override
feature of the DERS drug limits is activated. A device malfunction can result in an
increased risk of over-infusion or under-infusion if the infusion is started with
this rate value. This can cause serious adverse health consequences, including
death.
These products were manufactured from Oct. 1, 2011 through June 27, 2013 and
distributed from Oct. 6, 2011 through June 28, 2013. Refer to the the FDA Recall
Notice for a listing of affected part numbers.
The MRidium 3860+ Infusion pumps are intended for general hospital or
clinical use by medical professionals whenever it is required to infuse patients
with fluids and/or medications into the vein (intravenous) or through the artery
(intra-arterial) before, during or after Magnetic Resonance Imagining (MRI) scans.
The MRidium 1145 Dose Reduction System (DERS) drug library kit is an accessory
intended for use with the MRidium 3860+ Infusion Pump System.
Iradimed Corporation notified its customers by phone and on July
1, 2013 they sent an URGENT MEDICAL DEVICE RECALL NOTICE to all customers. The
notice described the product, problem and actions to be taken. Customers were
instructed to identify the MRidium 3860+ Infusion Pumps which have the 1145 DERS
Library card (AM05) installed. If these are not installed, no further action is
required at this time. However, if the DERS Library card is installed, remove the
1145 DERS Library Card from the 3860 Pump using the instructions provided in the
URGENT MEDICAL DEVICE RECALL NOTICE.
The product will be repaired (reconditioned) by installing a software upgrade that
corrects this problem. The updated software (version 3.5.1) can be seen during the
3860+ Pump's power on cycle.

Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections - Update[*Update* 08/10/2013] Specialty Compounding, LLC has announced a voluntary
nationwide recall of all lots of unexpired sterile products. The recall applies to
all unexpired sterile compounded products dispensed since May 9, 2013, including all
strengths and dosage forms. The recall was initiated after reports of bacterial
infection affecting 15 patients at two Texas hospitals, Corpus Christi Medical
Center Doctors Regional and Corpus Christi Medical Center Bay Area, whose treatment
included IV infusions of calcium gluconate from Specialty Compounding. There is a
potential association between the infections and the medication at this time.

Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections
Bacterial infections have been potentially associated with contaminated
calcium gluconate infusions produced by Specialty Compounding, Cedar Park, TX.
FDA has received reports of 15 adverse events experienced by patients in two
hospitals. The 15 patients received an infusion of calcium gluconate 2 grams in
Sodium Chloride 0.9% for Injection, which was supplied by Specialty Compounding. The
patients then developed bacterial bloodstream infections caused by Rhodococcus equi.
These infections are thought to be related to the infusions. Cultures from an intact
sample of calcium gluconate compounded by Specialty Compounding show growth of
bacteria that are consistent with Rhodococcus species.
FDA is working closely with the Centers for Disease Control and Prevention (CDC) and
the Texas state officials to investigate the cause of these bacterial infections.
Calcium gluconate by infusion can be used to treat conditions
associated with low calcium levels in certain circumstances.
FDA is alerting health care professionals not to use any sterile
products supplied by Specialty Compounding, Cedar Park, TX.

Cordis Optease Retrievable Inferior Vena Cava (IVC) Filter: Recall - Labeling
Correction
Cordis and FDA notified healthcare professionals and their organizations of
a product labeling correction to provide clarification and additional information to
minimize likelihood of implanting the filter backwards. This recall covers 33,000
units distributed in the United States between 05/06/2010 and 04/02/2013.
The Optease Retrievable Vena Cava Filter is used for the prevention of
recurrent pulmonary embolism in patients under specific situations. The device is
implanted into the inferior vena cava and is designed to be retrieved when the
patient no longer requires a filter.
On 4/3/2013, Cordis Corporation sent an "URGENT Medical Device
Correction" letter to their customers in the U.S. and Canada. Customers were
instructed to read the description and recommendations sections of the Instructions
for Use then sign and return an Acknowledgement Form directly to Cordis.

CareFusion Alaris PC unit (model 8015) with version 9.12 Keyboard Processor: Class I
Recall - Potential Loss of Communication Between Main Processor and Keyboard
CareFusion has reported that if the Alaris PC unit model 8015 voltage is
1.4 volts, rather than the 1.8 volts required for operation, the device could
potentially experience a loss of communication between the PC Unit main Processor
and Keyboard Processor. A device malfunction can result in the sudden unintended
discontinuation of medications.
When the Alaris PC unit model 8015 experiences a communication error, the unit will
display either a "SYSTEM ERROR" or "CHANNEL DISCONNECTED" error message. During the
communication error, the programmed infusion(s) will run as previously programmed;
however no further key presses on the Alaris PC unit have an effect on the system,
including "PAUSE" and "SILENCE" keys. The user may terminate all infusions by
pressing the "SYSTEM ON" key. Termination of an infusion could result in serious
injury or death.
The Alaris PC unit (model 8015) is part of the Alaris electronic
infusion pump. An electronic infusion pump delivers controlled amounts of
medications or other fluids to patients through intravenous (IV), intra-arterial
(IA), epidural, and other acceptable routes of administration.
On June 17, 2013, CareFusion issued an Urgent Medical Device
Recall to all affected customers with required actions for users. A CareFusion
representative will contact all affected customers within 60 days to provide an
update to correct the voltage on the keyboard processor. CareFusion does not require
customers to return their devices.

Acetaminophen: Drug Safety Communication - Association with Risk of Serious Skin
Reactions
Dermatology, Primary Care, Pharmacy
FDA notified healthcare professionals and patients that acetaminophen has
been associated with a risk of rare but serious skin reactions. Acetaminophen is a
common active ingredient to treat pain and reduce fever; it is included in many
prescription and over-the-counter (OTC) products. These skin reactions, known as
Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute
generalized exanthematous pustulosis (AGEP), can be fatal. These reactions can occur
with first-time use of acetaminophen or at any time while it is being taken. Other
drugs used to treat fever and pain/body aches (e.g., non-steroidal anti-inflammatory
drugs, or NSAIDS, such as ibuprofen and naproxen) also carry the risk of causing
serious skin reactions, which is already described in the warnings section of their
drug labels.
This new information resulted from the Agency’s review of the FDA
Adverse Event Reporting System (FAERS) database and the medical literature to
evaluate cases of serious skin reactions associated with acetaminophen (see Data
Summary at link below). It is difficult to determine how frequently serious skin
reactions occur with acetaminophen, due to the widespread use of the drug,
differences in usage among individuals (e.g., occasional vs. long-term use), and the
long period of time that the drug has been on the market; however it is likely that
these events (i.e., SJS, TEN, and AGEP) occur rarely.
Health care professionals should be aware of this rare risk and
consider acetaminophen, along with other drugs already known to have such an
association, when assessing patients with potentially drug-induced skin reactions.
Any patient who develops a skin rash or reaction while using acetaminophen or any
other pain reliever/fever reducer should stop the drug and seek medical attention
right away. Anyone who has experienced a serious skin reaction with acetaminophen
should not take the drug again and should contact their health care professional to
discuss alternative pain relievers/fever reducers.
FDA will require that a warning be added to the labels of prescription drug products
containing acetaminophen to address the risk of serious skin reactions. FDA will
also request that manufacturers add a warning about serious skin reactions to the
product labels of OTC acetaminophen drug products marketed under a new drug
application and will encourage manufacturers of drug products marketed under the OTC
monograph do the same.

DePuy Orthopaedics - LPS Lower Extremity Dovetail Intercalary Component: Class 1
Recall - Potential for Fracture of Device
FDA and DePuy Orthopaedics notified healthcare professionals of the class 1
recall of the LPS Lower Extremity Dovetail Intercalary Component due to the
potential for fracture of the female component, at the dovetail, when exposed to
normal physiologic loads while walking. This may also lead to additional pain,
infection, loss of function, loss of limb, neurovascular injury or need for revision
surgery. Patients greater than 200 pounds and/or those with high levels of activity
are at higher risk of fracture.
The LPS Lower Extremity Dovetail Intercalary component is intended for
replacement of the mid-shaft portion of the femur, top (proximal), bottom (distal)
and/or total femur, and top (proximal) tibia, especially in cases that require
extensive resection (i.e. tumors, trauma, infections, etc.).
On July 11, 2013 DePuy issued an Urgent Medical Device Recall
informing DePuy distributors, hospitals and surgeons of the problem and
to immediately stop distributing or using the recalled lots. DePuy is providing a
patient letter template to assist surgeons with notifying and discussing the risks
of the implant fracture and the method for detecting implant failure with their
patients. DePuy is not recommending revision or additional follow up in the absence
of symptoms of patients with this implanted device.Read the complete FDA recall
notice, linked below, for further recommendations and a list of affected product
codes and lot numbers.

Healthy Life Chemistry By Purity First B-50: FDA Health Risk Warning - Undeclared
Ingredients
[*UPDATE *8/01/2013] - Purity First Health Products is recalling two lots of Healthy
Life Chemistry B-50 (100 capsules), one lot of Healthy Life Chemistry Multi-Mineral
(200 capsules) and all lot numbers for Healthy Life Chemistry Vitamin C (200
capsules). The B-50 capsules were found on testing by FDA to contain Methasterone (a
schedule III controlled substance) and Dimethazine. Testing of the Multi-Mineral and
Vitamin C capsules appear to indicate the presence of Dimethyltestosterone.
The following products are marketed as Dietary Supplements and are packaged in white
plastic bottles:
• B-50, 100 capsule bottles, lot numbers F03Q and C02R
• Multi-Mineral, 200 capsule bottles, lot number 12-829
• Vitamin C, 200 capsule bottles, lot number E03Q
These recalled products were distributed nationwide via the internet, retail and
through retail stores between July 2012
thru June 2013.
Immediately discontinue the use of this product and return it to the place of purchase.

Beacon Hill Medical Pharmacy/Rxtra Solutions: Recall - Lack of Sterility Assurance
Beacon Hill Medical Pharmacy and FDA is notifying health professionals and
consumers of the recall of all lots of certain sterile products. FDA has raised a
question of sterility assurance for the affected products.The products were
distributed nationwide to outlets including hospitals, clinics, and patients who
have received orders by directly placing phone calls or faxed prescriptions to the
Beacon Hill Medical pharmacy facility in Southfield,Michigan.
Microbial contamination of products intended to be sterile can lead to
serious infections, which may be life-threatening.
The list of sterile injectable products compounded by Beacon
Hill/Rxtra Solutions and under recall, in alphabetical order, organized by drug name
and strength can be found in the firm's press release at the link below. The
products can be identified by lot numbers starting with code 01012013@1 to
07262013@99.

GE Healthcare Nuclear Medicine Systems: Class I Recall - Serious Injuries or Deaths
Could Occur
Nuclear Medicine, Radiology, Risk Manager, Biomedical Engineering
GE Healthcare became aware of an incident at a VA Medical Center facility
in the US. A patient died due to injuries sustained while being scanned on an
Infinia Hawkeye 4 Nuclear Medicine System. On July 03, 2013 GE notified hospitals
that they were recalling several Nuclear Medicine Imaging Systems because serious
injuries or deaths could occur due to the failure mode associated with this recall.
These Nuclear Medicine systems are used to perform general Nuclear
Medicine imaging procedures for detection of radioisotope tracer uptake in the
patient’s body, using a variety of scanning modes supported by various acquisition
types and optional imaging features designed to enhance image quality in Oncology,
Cardiology, Neurology and other clinical diagnostic imaging applications.
Affected products include: Infinia Nuclear Medicine Systems, VG and VG Hawkeye
Nuclear Medicine Systems, Helix Nuclear Medicine Systems, Brivo NM615, Discovery
NM630, Optima NM/CT640, Discovery NM/CT670 (refer to the Recall Notice for a list of
affected Models).
Healthcare facilities are instructed to cease use of their Nuclear
Medicine system until a GE Healthcare Field Engineer is able to do a complete
inspection of the system and perform any necessary repairs at no cost. A GE
Healthcare representative will contact the hospitals to arrange for the inspection.

Nova Max Glucose Test Strips: Recall - May Report False, Abnormally High Blood
Glucose Result
Nova Diabetes Care initiated a voluntary recall of 21 lots of the Nova Max
Glucose Test Strips distributed both in the USA and outside the continental USA.
Nova Max Plus glucose meter kits that include test strips from the recalled lots are
also included in this voluntary recall.
The company has recently determined that some of the blood glucose test strips
contained within the indicated Nova Max Glucose Test Strip lots and Nova Max Plus
glucose meter kits may report a false, abnormally high blood glucose result. A false
abnormally high blood glucose result could, under certain conditions, result in an
insulin dosing error that could lead to a serious health risk requiring immediate
medical attention.
Upon identifying the issue, Nova Diabetes Care promptly notified all
registered users, health care professionals, pharmacies, and distributors where the
Nova Max Glucose Test Strip and Nova Max Plus glucose meter kit are recommended or
sold.
Those who use, recommend clinically, or sell Nova Max Glucose Test
Strips for blood glucose testing should immediately discontinue using or
distributing glucose test strips from the recalled lots (see the Recall Notice for a
listing of recalled lots).

Mefloquine Hydrochloride: Drug Safety Communication - Label Changes Due To Risk of
Serious Psychiatric and Nerve Side Effects
FDA is advising the public about strengthened and updated warnings
regarding neurologic and psychiatric side effects associated with the antimalarial
drug mefloquine hydrochloride. A boxed warning, the most serious kind of warning
about these potential problems, has been added to the drug label. FDA has revised
the patient Medication Guide dispensed with each prescription and wallet card to
include this information and the possibility that the neurologic side effects may
persist or become permanent. The neurologic side effects can include dizziness, loss
of balance, or ringing in the ears. The psychiatric side effects can include feeling
anxious, mistrustful, depressed, or having hallucinations.
Mefloquine hydrochloride is indicated for the treatment of mild to
moderate acute malaria caused by mefloquine-susceptible P. falciparum and P. vivax,
and prevention of malaria infections by P. falciparum (including
chloroquine-resistant P. falciparum) and P. vivax. It was previously marketed under
the brand name Lariam; however, the Lariam product is not currently marketed.
Generic mefloquine products are available in the US.
Patients, caregivers, and health care professionals should watch
for these side effects. When using the drug to prevent malaria, if a patient
develops neurologic or psychiatric symptoms, mefloquine should be stopped, and an
alternate medicine should be used. If a patient develops neurologic or psychiatric
symptoms while on mefloquine, the patient should contact the prescribing health care
professional. The patient should not stop taking mefloquine before discussing
symptoms with the health care professional.

Healthy Life Chemistry By Purity First B-50: FDA Health Risk Warning - Undeclared
Ingredients
FDA is warning consumers that they should not use or purchase Healthy Life
Chemistry By Purity First B-50, marketed as a vitamin B dietary supplement. A
preliminary FDA laboratory analysis indicated that the product contains two
potentially harmful anabolic steroids—methasterone, a controlled substance, and
dimethazine. These ingredients are not listed in the label and should not be in a
dietary supplement.
The FDA has received reports of 29 adverse incidents associated with
the use of Healthy Life Chemistry By Purity First B-50. These reports include
fatigue, muscle cramping, and myalgia (muscle pain), as well as abnormal laboratory
findings for liver and thyroid function, and cholesterol levels. Females who used
this product reported unusual hair growth and missed menstruation, and males who
used the product reported impotence and findings of low testosterone.
Health care professionals are advised to ask their patients about
any dietary supplements they may be using, particularly in patients exhibiting
warning signs that may be associated with the use of steroids or steroid-like
substances. These warning signs include liver injury, kidney failure and stroke.
They also include hormone-associated adverse effects such as blood clots, including
pulmonary embolism (a sudden blockage in a lung artery), and deep vein thrombosis (a
blood clot that forms in a vein deep in the body, often in the lower leg or thigh).
Consumers using Healthy Life Chemistry By Purity First B-50 who experience symptoms
should consult a health care professional and report their experience to the FDA.

Nizoral (ketoconazole): Drug Safety Communication - Potentially Fatal Liver Injury,
Risk of Drug Interactions and Adrenal Gland Problems*
FDA is taking several actions related to Nizoral (ketoconazole) oral
tablets, including limiting the drug’s use, warning that it can cause severe liver
injuries and adrenal gland problems, and advising that it can lead to harmful drug
interactions with other medications. FDA has approved label changes and added a new
Medication Guide to address these safety issues. As a result, Nizoral oral tablets
should not be a first-line treatment for any fungal infection. Nizoral should be
used for the treatment of certain fungal infections, known as endemic mycoses, only
when alternative antifungal therapies are not available or tolerated.
"Liver Injury (Hepatotoxicity)"
Nizoral tablets can cause liver injury, which may potentially result in liver
transplantation or death. FDA has revised the Boxed Warning, added a strong
recommendation against its use (contraindication) in patients with liver disease,
and included new recommendations for assessing and monitoring patients for liver
toxicity.
"Adrenal Insufficiency"
Nizoral tablets may cause adrenal insufficiency by decreasing the body’s production
of corticosteroids.
"Drug Interactions"
Nizoral tablets may interact with other drugs a patient is taking and can result in
serious and potentially life-threatening outcomes, such as heart rhythm problems.
Nizoral (ketoconazole) is indicated for the treatment of fungal
infections when alternatives are not available or not tolerated. The topical
formulations of Nizoral have not been associated with liver damage, adrenal
problems, or drug interactions. These formulations include creams, shampoos, foams,
and gels applied to the skin, unlike the Nizoral tablets, which are taken by mouth.
Nizoral tablets should be used only for the treatment of certain
life-threatening mycoses when the potential benefits outweigh the risks and
alternative therapeutic options are not available or tolerated. Healthcare
professionals should assess the liver status of the patient before starting oral
ketoconazole, and monitor serum ALT levels during treatment. Adrenal function should
be monitored in patients with adrenal insufficiency or with borderline adrenal
function and in patients under prolonged periods of stress (major surgery, intensive
care, etc.). Review all concomitant medications for the potential for drug
interactions with Nizoral tablets.

LeMaitre Vascular, Inc., Albograft Vascular Graft: Class I Recall - Blood Leak
Models: AMC1408, AMC1506, AMC1608, AMC1809, AMC1810, AMC2010, AMC4007, AMC4008,
AMC6006, AMC6007, AMC6008, ATC1526, ATC1530, ATC3016, ATC3018, ATC3024, ATC3026,
Batch 56890A
LeMaitre Vascular, Inc. recalled the Albograft Vascular Graft due to blood
leaking from the surface of the graft after implantation. This product may cause
serious adverse health consequences, including death.
Within the U.S., this device was only distributed in Pennsylvania.
This device was manufactured in April 2011, and distributed from April 2011, through
June 2013.
The Albograft Vascular Graft is made of synthetic material. It is
designed to replace or repair a damaged artery with an abnormal enlargement
(aneurysm) or a blockage (occlusion) caused by a disease.
On June 19 2013, the firm sent an Urgent Field Safety Notice dated
June 19, 2013, to all affected customers. Customers were instructed to identify and
return the affected devices to LeMaitre Vascular. They in turn will replace the
devices.

Diabetes Treatments: FDA Alerts of Illegal Sales - Undeclared Ingredients
FDA is taking action to remove from the market illegal products, including
some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent
diabetes and related complications. To date, the FDA is not aware of any reports of
injury or illness associated with the illegally sold products, but is taking action
to protect the public health from potential harm related to these violative
products.
These illegally sold products include:
* Products sold as “natural” treatments for diabetes, but containing undeclared
active pharmaceutical ingredients in unknown quantities that could cause harm or
complicate medical conditions;
* Dietary supplements and ayurvedic products (medicine of the healing arts that
originated in India) with claims to treat, cure, and/or prevent diabetes;
* Unapproved drugs sold over-the-counter, including some homeopathic products,
intended to treat complications associated with diabetes, which include relieving
symptoms caused by nerve damage in the arms and legs (also called peripheral
neuropathy); and
* Prescription drugs for diabetes sold by online pharmacies without a prescription.
FDA-approved diabetes treatments, prescribed by a licensed health care
professional and shown to be safe and effective, are readily available for people
with diabetes. Many of the illegally sold products that are the subject to this
action include claims such as “prevents and treats diabetes,” and “can replace
medicine in the treatment of diabetes.” FDA recently issued letters warning 15
companies that the sale of their illegally marketed diabetes products violates
federal law. The FDA has requested a written response from these companies within 15
business days stating how the companies will correct the violations. Failure to
promptly correct the violations may result in legal action, including product
seizure, injunction, and/or criminal prosecution.
FDA is advising consumers not to use these or similar products
because they may contain harmful ingredients or may be otherwise unsafe, or may
improperly be marketed as over-the-counter products when they should be marketed as
prescription products. Using these products could cause consumers to delay seeking
proper medical treatment for their diabetes.

MedStream Programmable Infusion Pump: Class 1 Recall - Malfunction In The Fill Level
Sensor
The Fill Level Sensor (FLS), a component of the Medstream Programmable
Infusion Pump, may malfunction. The Fill Level Sensor is intended to measure the
contents of the pump drug reservoir. The malfunction in the Fill Level Sensor may
cause the pump’s low reservoir alarm, normally set at 3 ml, to sound too early or
too late.
These affected products were distributed from July, 2009 through June,
2013 and include Models 91-4200US 20 ml pump, .91-4201US 40 ml pump, 91-4200 20 ml
pump, 91-4201 40 ml pump
On June 07, 2013, Codman issued a Medical Device Corrections
Notice1 2 to consignees to inform them of a potential problem with the MedStream
Programmable Infusion Pump. The notice directed clinicians to evaluate the accuracy
of the Fill Level Sensor, during each patient’s next scheduled refill session, or
sooner if the patient is symptomatic. The firm provided a worksheet (step by step
instructions) to identify pumps with a miscalibrated Fill Level Sensor and
management recommendations for patients with affected devices. No action for
physicians is required beyond the recommendations provided in the Medical Device
Corrections Notification letter.

Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: Class 1 Recall - Mislabeled
Packaging
The outside of the device packaging stated a 3.0mm neonatal tube. The
product inside the box was actually a 3.0mm pediatric tube. Although the neonatal
and pediatric tubes have the same inner diameter, the pediatric tube is 4.0mm longer
for this particular model.
An oversized tracheostomy tube may cause permanent injury to the trachea. This
product may cause serious adverse health consequences, including death.
The Tracoe Mini 3.0mm Tracheostomy Tube is intended to be placed into
a surgical opening of the trachea (windpipe) to provide safe airway access and to
remove discharge from the lungs. These devices are indicated for use in neonatal and
pediatric patients.
The affected products (Model: 350-3.0, Lot Number: 000-1000071752) were manufactured
from December 12, 2012, to January 14, 2013, and distributed from April 9, 2013, to
April 12, 2013.
On April 17, 2013, the firm notified its customers of the problem
by telephone and asked them to return affected devices for replacement. For
questions about this recall, contact Bryan Medical, Inc. at 513-272-1600.

Medtronic MiniMed Paradigm Insulin Infusion Sets: Class 1 Recall - Potential for
Over or Under Delivery of Insulin
On June 7, 2013, Medtronic sent an urgent medical device safety
notification to healthcare professionals to inform them of the potential for over or
under delivery of insulin if insulin or other fluids contact the inside of Medtronic
Paradigm Tubing Connectors. On June 10, 2013 Medtronic sent an Urgent Medical Device
Safety Notification to all Paradigm Insulin pump users and distributors to inform them of this issue.
If insulin or other fluids come in contact with the inside of the tubing connector
it can temporarily block the vents that allow the pump to properly prime. This can
result in too much or too little insulin being delivered, resulting in hypoglycemia
or hyperglycemia, which can be severe and lead to serious illness.
Infusion sets are used by patients with diabetes mellitus who require
administered insulin to maintain acceptable blood glucose levels. The Paradigm
infusion sets are intended for use with Paradigm insulin infusion pumps.
Patients: if you notice anything unusual during the infusion set
prime process such as the insulin continuing to drip from the tip of the infusion
set cannula when priming has been completed, this may indicate that the connector
vents are not working properly. If this occurs, do not insert the infusion set and
immediately call the HelpLine at 1-888-204-7616 for assistance.

Verathon, Inc., GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2,
3, 4 and 5 Reusable Blades: Class I Recall - Risk of Blade Tip Breakage and
Premature Failure
GlideScope GVL and AVL reusable blades were recalled due to the potential
risk of breakage and premature failure of the blade tip. Device failure may not be
readily visible during routine inspection before or after insertion of the
laryngoscope. This could result in pieces of the blade breaking off in patients’
mouths and being swallowed or blocking the airway. This product may cause serious
adverse health consequences, including hypoxemia (low blood oxygen), severe cuts to
the airway leading to a significant loss of blood, and/or death.
The GlideScope Video Laryngoscope (GVL) and GlideScope Advanced Video
Laryngoscope (AVL) are used by qualified medical professionals to obtain a clear,
open view of the vocal cords for medical procedures.
On May 10, 2013, Verathon sent “Urgent Medical Devices Recall”
letters to all affected customers. The letter identified the problem, affected
product, and actions to be taken. Customers were advised to:
* Stop using affected devices
* Return affected devices to Verathon for replacement
* Complete the “Return Response” form

Estarylla (norgestimate and ethinyl estradiol): Recall - Report of Placebo Tablet
Present in Row of Active Tablets
Sandoz notified the public it is conducting a voluntary nationwide recall
to the retailer level of one lot of its Estarylla (norgestimate and ethinyl
estradiol) tablets in the US, following a customer report of a placebo tablet
present in a row of active tablets on one pack.
The lot number, expiration date, and NDC code of the recalled lot is: LF01213A,
expiration date 02/2014, NDC 00781-4058-15. It is supplied in cartons containing 3
blister cards of 28 tablets each. This lot was distributed to the US market only.
Estarylla is indicated for the prevention of pregnancy in women who
elect to use oral contraceptives as a method of contraception.
The Sandoz Drug Information Direct Line is open at 800-525-2492,
24 hours/day, seven days a week.

Olmesartan Medoxomil: Drug Safety Communication - Label Changes To Include
Intestinal Problems (Sprue-Like Enteropathy)
FDA is warning that the blood pressure drug Olmesartan Medoxomil (marketed
as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal
problems known as sprue-like enteropathy. Symptoms of sprue-like enteropathy include
severe, chronic diarrhea with substantial weight loss. FDA has approved changes to
the labels of these drugs to include this concern. Sprue-like enteropathy has not
been detected with ARB drugs other than olmesartan.
FDA will continue to evaluate the safety of olmesartan-containing products and will
communicate again if additional information becomes available.
Olmesartan medoxomil is an angiotensin II receptor blocker (ARB)
approved for the treatment of high blood pressure, alone or with other
antihypertensive agents, and is one of eight marketed ARB drugs.
Health care professionals should tell patients to contact them if
they develop severe, chronic diarrhea with substantial weight loss while taking an
olmesartan-containing product, even if it takes months to years for symptoms to
develop. Patients should contact their health care professional right away if they
take an olmesartan-containing product and experience severe diarrhea, diarrhea that
does not go away, or significant weight loss.

RECOMBIVAX HB (Hepatitis B Vaccine (Recombinant)) Adult Formulation by Merck Sharp
and Dohme Corp.: Recall - Potential For Cracked Vials
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Merck),
initiated this voluntary recall due to the potential for a limited number of cracked
vials to be present in the lot. Merck’s investigation concluded that for certain
vials in the affected lot, the potential exists for a crack to have occurred in the
vial. If the vial was cracked, the integrity of the vial and the sterility of any
product remaining in the vial could not be assured.
Lot Number J001183 of RECOMBIVAX HB Adult Formulation is the only lot
impacted by the recall and was distributed solely within the United States. The lot
was distributed by Merck between March 12, 2013 and May 2, 2013. There is adequate
inventory to replace recalled product at this time.
If product from this lot has been administered, revaccination is
not necessary. Customers are asked to inventory and quarantine all product from Lot
J001183 and follow Merck’s instructions for return of product.

Benztropine Mesylate Injection by Fresenius Kabi USA: Recall - Potential Presence Of
Glass Particles
Fresenius Kabi USA is voluntarily recalling four lots of Benztropine
Mesylate Injection, USP, 2 mg/2mL (1mg/mL) in 2 mL single dose vials due to the
potential presence of glass particles (glass delamination) in the vials. The defect
discovered in this product was noted as visible particulate. However, the process of
glass delamination may result in formation of visible and subvisible particles. No
adverse events, patient reactions or customer complaints have been reported to date.
Benztropine Mesylate is used as an adjunct in the therapy of all forms
of Parkinsonism. It is also useful in the control of extrapyramidal disorders due to
neuroleptic drugs, except tardive dyskinesia. The company has discontinued
distribution of Benztropine Mesylate while it investigates the cause. The product is
manufactured by Allergy Laboratories, Inc. and distributed by Fresenius Kabi USA.
The product may appear with "APP" or "Nexus Pharmaceuticals" labels. Recalled lot
numbers include 030712, 071212, 090512 and 111412.
All customers who received the recalled vials are being notified
and instructed to return any unused product to Fresenius Kabi USA. Health care
professionals can find additional information about the recall on the company's web
site www.apppharma.com or by calling Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through
Friday, between the hours of 8 a.m. and 5 p.m. (Central Time). Questions regarding
product availability and ordering can be directed to Fresenius Kabi USA Customer
Service at 1-888-386-1300, Monday through Friday, between the hours of 7 a.m. and 6
p.m. (Central Time).

Medtronic SynchroMed Implantable Infusion System Devices: Class 1 Recalls - Feed
Through Failure, Failure of Priming Bolus, and Catheter Occlusion*
06/28/2013
In June 2013, Medtronic, Inc. initiated four medical device notifications
to customers worldwide about the SynchroMed Implantable Infusion System. The Food
and Drug Administration (FDA) has classified three of these notifications as Class I
recalls. The fourth notification is an update to a 2011 action related to pump
refill which was previously classified by the FDA as a Class I recall.
Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps – Failure
of Priming Bolus
"Reason for Recall:" The SynchroMed Implantable Infusion Pumps are being
recalled because of the unintended delivery of drugs during the priming bolus
procedure. During this procedure, patients may receive the drug unintentionally at
a high rate of infusion in the cerebrospinal fluid (CSF) followed by a period of
reduced drug delivery after the priming bolus. This can result in a drug overdose
or under dose which can lead to serious medical illness such as respiratory
depression, coma or death.
"Products:" SynchroMed II, Model 8637 (20 ml or 40 ml reservoir size) and
SynchroMed EL Programmable Pumps, Models 8626, 8626L, 8627, 8627L (10 ml or 18 ml
reservoir size).
Medtronic recommends healthcare professionals continue using the priming bolus
procedure to ensure therapy is initiated while a patient is under medical
supervision. For Complete list of recommendations please see Class 1 Recall
Notice.
Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps – Feed
Through Failure
"Reason for Recall:" There is a potential for electrical shorting, internal to
the SynchroMed infusion pump. An electrical short circuit in a feedthrough may
present as a motor stall or low battery reset/alarm and may lead to a loss of or
reduction in therapy. This may result in the return of underlying symptoms and/or
withdrawal symptoms. Use of this recalled product may result in serious adverse
health consequences, including death.
"Products:" SynchroMed II, Model 8637 (20 ml or 40 ml reservoir size) and
SynchroMed EL Programmable Pumps, Models 8626, 8626L, 8627, 8627L (10 ml or 18 ml
reservoir size).
Medtronic Sutureless Connector Intrathecal Catheter Products – Catheter Occlusion
"Reason for Recall:" The Sutureless Connector Intrathecal Catheter connector has
been redesigned to reduce the potential for occlusion, which is the blockage or
stoppage of drug flow due to misalignment at the point where the catheter connects
to an implantable pump. Medtronic is removing all unused products that were
manufactured with the previous design. Medtronic recommends the previous design of
Sutureless Connector Intrathecal Catheter Products no longer be used due to
greater potential for misalignment and subsequent occlusion. This product may
cause serious adverse health consequences, including drug under dose, loss of
symptom relief, drug withdrawal symptoms caused by the lack of drug delivery to
the Intrathecal space, and/or death.
"Products:" Sutureless Connector Intrathecal Catheters, Models 8709SC, 8731SC
and Sutureless Revision Kits, Models 8596SC, 8578
Medtronic does not recommend the use of any affected devices with the old design.
SynchroMed Implantable Infusion Pump Refill Procedure Safety Update
Medtronic is distributing a revised Clinician Refill Reference Card with
information about the pump refill procedure for the SynchroMed Implantable
Infusion System. This is a continuation of a 2011 notification that was previously
classified as a Class I recall. The revised reference card reflects new product
labeling approved by the FDA to help healthcare professionals reduce the potential
for a pocket fill during the SynchroMed pump refill procedure. A pocket fill is
the inadvertent injection during a refill procedure of all or some of the
prescribed drug into the patient's subcutaneous tissue, which includes the pump
pocket (area under the skin where the pump is placed), instead of into the pump.
Medtronic's intrathecal drug delivery systems are used to treat
chronic, intractable pain and severe spasticity of cerebral or spinal origin.
The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps (SynchroMed
Implantable Infusion Pumps) contain and administer prescribed drugs to a specific
site inside the patient’s body. Currently, the approved drugs for use with the
SynchroMed Infusion Pump are Infumorph, Lioresal, Prialt (Ziconotide), Floxuridine,
Methotrexate and Gablofen. The SynchroMed pumps are used to treat primary or
metastatic cancer, chronic pain, and severe spasticity. The implantable components
of the SynchroMed II infusion system include the pump, catheter, and catheter
accessories.
The Sutureless Connector Intrathecal Catheter and Revision Kits are accessories to
an implanted infusion system designed to store and deliver parenteral drugs to the
Intrathecal space. The implanted infusion system components consist of a Medtronic
SynchroMed implantable drug infusion pump and an Intrathecal Catheter. The
Sutureless Revision Kit is used when a pump connector for an Intrathecal Catheter is
required.
These notifications provide clinicians with information to help
identify and manage issues that impact the safe and reliable delivery of therapy
using the SynchroMed Implantable Infusion System. Patients and caregivers should be
aware of the signs and symptoms associated with intrathecal drug therapy
complications and contact their physicians immediately if they hear a device alarm
or experience symptoms of a drug overdose or underdose. Patients are encouraged to
maintain regular follow-up appointments with their physicians; however, if they
experience a change or return of symptoms or hear a device alarm, they should
contact their physician immediately.

Hydroxyethyl Starch Solutions: FDA Safety Communication - Boxed Warning on Increased
Mortality and Severe Renal Injury and Risk of Bleeding
FDA has analyzed recent data that indicate an increased risk of (i)
mortality and renal injury requiring renal replacement therapy in critically ill
adult patients, including patients with sepsis and those admitted to the ICU; and
(ii) excess bleeding particularly in patients undergoing open heart surgery in
association with cardiopulmonary bypass. Refer to the FDA Safety Communication for
more details about the data analysis.
FDA has concluded that HES solutions should not be used in critically ill adult
patients, including patients with sepsis and those admitted to the ICU, and a Boxed
Warning to include the risk of mortality and severe renal injury is warranted. In
addition, FDA has reviewed a meta-analysis of studies conducted in patients
undergoing open heart surgery in association with cardiopulmonary bypass and has
determined that an additional warning about excessive bleeding is needed in the
Warnings and Precautions Section of the package insert.
Hydroxyethyl starch (HES) solutions are used for the treatment of
hypovolemia (low blood volume) when plasma volume expansion is desired. Recent data
have associated the use of these products with an increased risk of severe adverse
events when used in certain patient populations.
Patients should be aware of the risks associated with the use of
HES solutions and discuss these risks with their healthcare provider (refer to the
FDA Safety Communication for detailed recommendations for patients).
Recommendations for Health Professionals include the following:
* Do not use HES solutions in critically ill adult patients including those with
sepsis, and those admitted to the ICU.
* Avoid use in patients with pre-existing renal dysfunction.
* Discontinue use of HES at the first sign of renal injury.
* Need for renal replacement therapy has been reported up to 90 days after HES
administration. Continue to monitor renal function for at least 90 days in all
patients.
* Avoid use in patients undergoing open heart surgery in association with
cardiopulmonary bypass due to excess bleeding.
* Discontinue use of HES at the first sign of coagulopathy.

Medtronic Xomed NIM Trivantage EMG Endotracheal Tube: Class I Recall - Cuff Leak or
Cuff Deflation When Inflation Valve Cap Inappropriately Removed
FDA notified healthcare professional of a Class I Recall of the Medtronic
Xomed, Inc. NIM Trivantage EMG Endotracheal Tube. The firm received complaints of
"cuff leak" or "cuff deflation" occurring when the inflation valve cap is
inappropriately removed (pulled off, instead of snapped-off sideways). This requires
the physician to re-inflate or replace the deflated tube to ensure the continued
breathing support of the patient. Use of this recalled product can result in serious
adverse health consequences, including death.
See the Recall Notice for a listing of affected Lot numbers.
The NIM Trivantage Endotracheal Tube is used by health care
professionals to continuously monitor the voice box (laryngeal) muscles during
surgery. The device keeps the patient’s airway open for ventilation and for
electromyography (EMG) monitoring of the laryngeal muscles when connected to an
appropriate EMG monitor.
On March 14, 2013, the firm sent an "URGENT Product Recall
Notification" letter to its customers. Customers were instructed to return any
affected devices still in their possession. Contact Medtronic ENT Customer Service
at 1-800-874-5797 to arrange for returns.

Respironics California, Inc. - Class 1 Recall: V60 Ventilators - Issue with software
Respironics California, Inc. has initiated a recall on the V60 ventilator
because of an issue with the software on the V60 Power Management Board Assembly. If
a component fails on the Power Management Board Assembly, it may cause ventilator
support to be lost with potentially no audible alarm from the ventilator. This
recalled product may cause serious adverse health consequences, including death.
The recalled products were distributed from November 16, 2009 through March 28, 2013.
On June 3, 2013, Philips Healthcare sent a "MEDICAL DEVICE CORRECTION"
letter to all customers who received the V60 Ventilators. The letter described the
product, the problem, and the actions to be taken.
Customers were informed that the V60 ventilator may continue to be
used according to its directions for use, pending the completion of the software
update. In addition, customers were instructed to refer to their manual for
additional information on warnings.
A Philips Field Service Engineer, Approved Service Provider, or Distributor will be
contacting customers to schedule a no-cost update and replacement of the Power
Management Board Assembly Software on all V60 ventilators shipped from the
manufacturer prior to April 1, 2013.

Enteric Coated Aspirin 81 mg Tablets by Advance Pharmaceutical Inc.: Recall of One
Lot - May Contain Acetaminophen 500 mg Tablets*
06/19/2013
Advance Pharmaceutical Inc. announced that this firm is conducting a
voluntary nationwide recall to the user level of the over-the-counter drug product,
Rugby label Enteric Coated Aspirin Tablets, 81 mg, Lot 13A026. Advance
Pharmaceutical Inc. first initiated the recall on June 17, 2013, after receiving a
complaint about a bottle labeled as Enteric Coated Aspirin Tablets, 81 mg, actually
containing Acetaminophen 500 mg tablets. Consumers may be inadvertently taking
Acetaminophen 500 mg instead of Enteric Coated Aspirin 81 mg which may cause severe
liver damage to those who take other drugs containing acetaminophen, consumers who
take 3 or more alcoholic drinks every day, or those who have liver disease. The
labeled directions instructs patients to take 4-8 tablets every 4 hours, but not
more than 48 tablets in 24 hours. Consumers who take 48 tablets daily of the
defective product may be ingesting up to 24,000 mg of Acetaminophen, which is about
six times the maximum recommended daily dose of acetaminophen (4,000 mg).
The product is indicated for the temporary relief of minor aches and
pains and is packaged in bottles of 120 tablet with NDC 0536-3086-41 and UPC 3
0536-3086-41 9. The affected lot of Enteric Coated Aspirin Tablets is Lot 13A026
with Expiration Date 01-2015. The lot was manufactured and packaged by Advance
Pharmaceutical Inc. under the label of Rugby Laboratories. Rugby Laboratories (Major
Pharmaceuticals) distributed the product nationwide to wholesalers and retailers.
Advance Pharmaceutical Inc. notified Rugby Laboratories of the recall by e-mail and
overnight mail, and is arranging for return of all recalled bottles.
Consumers who have the affected lot should immediately discontinue
its use and return it to the pharmacy or store where it was purchased. Consumers
should contact their physician or healthcare provider if they have experienced any
problems that may be related to taking or using this product.

Zyprexa Relprevv (Olanzapine Pamoate): Drug Safety Communication - FDA Investigating
Two Deaths Following Injection
Health Professional, Pharmacy, Patient
FDA is investigating two unexplained deaths in patients who received an
intramuscular injection of the antipsychotic drug Zyprexa Relprevv (olanzapine
pamoate). The patients died 3-4 days after receiving an appropriate dose of the
drug, well after the 3-hour post-injection monitoring period required under the
Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS). Both patients were
found to have very high olanzapine blood levels after death.
Under the REMS, patients are required to receive the Zyprexa Relprevv
injection at a REMS-certified health care facility, to be continuously monitored at
the facility for at least 3 hours following an injection, and to be accompanied home
from the facility. The Zyprexa Relprevv label contains warnings about the risk of
post-injection delirium sedation syndrome (PDSS), a serious condition in which the
drug enters the blood too fast following an intramuscular injection, causing greatly
elevated blood levels with marked sedation (possibly including coma) and/or delirium
FDA is providing this information to health care professionals
while it continues its investigation. If therapy with Zyprexa Relprevv is started
or continued in patients, health care professionals should follow the REMS
requirements and drug label recommendations. Patients and caregivers should talk to
their health care professional(s) about any questions or concerns.

Inc. AFX Introducer System: Class 1 Recall - Reports Of Dilator Breaking
During Procedures
On May 13, 2013, Endologix, Inc. initiated a recall of AFX Introducer
System Model S17-45 due to reports of the dilator breaking during procedures.
The AFX Introducer System is intended to help introduce catheters and
other medical devices into blood vessels during procedures with minimal blood loss.
This recalled product was distributed and manufactured from April 1, 2013 through
April 30, 2013 and distributed in the U.S. only in Florida, Indiana, Michigan, New
Hampshire, New Jersey and New York. Affected lot numbers include 1079840, 1079843,
1079844, 1079845.
On May 13, 2013, Endologix sent its customers an Urgent Medical
Device Recall Notice letter stating "Do not use or further distribute any affected
product.” The firm also instructed their customers to share this information with
physicians who perform these procedures at their facilities. On May 21 the firm
expanded the recall by mailing a recall notification letter to an additional
customer. Customers may contact the firm with questions at 1-800-983-2284.

Warfarin 2 mg Tablets by Zydus Pharmaceuticals USA Inc.: Recall - Due to Oversized
Tablet
Zydus Pharmaceuticals USA Inc. is voluntarily recalling one lot of Warfarin
2 mg Tablets, Lot #MM5767, expiration date June 2014 to the retail level. Four
tablets of Warfarin 2 mg Tablets, Lot MM5767, have been found to be oversized in one
product complaint.
Ingestion of a greater than intended dose of Warfarin, could lead to an increased
pharmacological effect of warfarin. As a result, patients would be more likely to
develop bleeding as an adverse reaction and in some patients that bleeding into a
critical organ (mostly the central nervous system) could be fatal. The risk of
bleeding is increased if overdosing is repeated continuously on a daily basis.
The product is used as prophylaxis and treatment of venous thrombosis
and its extension, pulmonary embolism (PE), prophylaxis and treatment of
thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac
valve replacement and reduction in the risk of death, recurrent myocardial
infarction (MI), and thromboembolic events such as stroke or systemic embolization
after myocardial infarction. Product is packaged in HDPE Bottle of 1000's count,
which may have been dispensed to patients in smaller bottles. The only lot affected
of Warfarin 2 mg Tablets being recalled is Lot MM5767.
The product can be identified by its NDC #6838205310. The product was distributed
nationwide in the United States to wholesalers/distributors, retailers and mail
order providers, from November 2012 to December 2012.
Consumers should contact their physician or healthcare provider if
they have experienced any problems that may be related to taking or using this
particular lot of Warfarin 2 mg Tablets. Anyone with an existing inventory of this
particular Lot MM5767 of Warfarin 2 mg Tablets should stop use and distribution,
quarantine the recalled lots immediately and call INMAR at 1-800-967-5952 between
the hours of 7 a.m. to 4 p.m. CST, Monday through Friday, to arrange for their
return. In case patients have tablets of this lot of product, make sure all the
tablets are of same size and if unsure, patients should consult their dispensing
pharmacy.

Symbios GOPump and GOBlock Kits: Class 1 Recall - Potential for Excessive High Flow
Rates
FDA and Symbios are informaing the public of a recall of all GoPump Rapid
Recovery System kits and GOBlock Kits manufactured with flow control components
assembled prior to July 2012.The affected products may have excessively high flow
rates. As a result, medications could be delivered too quickly from the balloon to
the surgical site and cause patient toxicity due to the rapid influx of medication.
This can lead to serious illness, including seizure, abnormal heart rhythms and
death. Elderly patients and patients with low body mass are at high risk of these
complications.
The Symbios GOPump Rapid Recovery System is a disposable local pain
management system that consists of a small balloon that is inflated with a local
anesthetic medication. The medication is delivered slowly through tubes from the
balloon to the surgical site.
Please see the Recall Notice with listing of all the lot numbers
affected. Customers who have purchased the affected devices were notified by letter
dated May 10, 2013 about the problem. Follow-up letters were sent on May 14, 2013
and May 30, 2013 notifying customers of additional recalled lots. Symbios is working
to secure all affected product and have it returned.

Vecuronium Bromide For Injection by Sagent Pharmaceuticals, Inc.: Recall - Elevated
Impurity Result Detected
Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of
three lots of Vecuronium Bromide for Injection 10mg (NDC number 25021-657-10)
manufactured by Mustafa Nevzat Ilac Sanayii A.S. (MN Pharmaceuticals) and
distributed by Sagent. Sagent has initiated this voluntary recall of Vecuronium
Bromide for Injection to the user level due to the discovery of an elevated
impurity result detected during routine quality testing of stability samples at the
18-month interval. The elevated impurity result has the potential to result in
prolonged neuromuscular blockade for critically ill patients with renal failure.
Vecuronium Bromide for Injection is a neuromuscular blocking agent
indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation
and to provide skeletal muscle relaxation during surgery or mechanical ventilation
and is supplied in a glass vial. The lot numbers being recalled are: 11I30481A,
11I30721A and 11I32581A, which were distributed to hospitals, wholesalers and
distributors nationwide from January 2012 through May 2012. Sagent is not aware of
any adverse patient events resulting from the use of this product and is continuing
its diligent investigation of the situation.
Sagent’s Distributor, DDN, is notifying Sagent’s distributors and
customers by fax, email and certified mail and is arranging for return of all
recalled product. Customers have been instructed to examine their inventory
immediately and to quarantine, discontinue distribution of and return all recalled
lots of the product. Consumers should contact their physician or healthcare provider
if they have experienced any problems that may be related to taking or using this
product. Any questions about returning unused product should be directed to the
customer call center at (866) 625-1618 M-F 8am-7pm CST.

Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of
Adverse Reactions Associated with Steroid Injections
UPDATE 06/07/2013 FDA has identified bacterial and fungal growth in samples from
two unopened vials of preservative-free (PF) methylprednisolone acetate (MPA) 80
mg/mL, 10mL vials form Main Street Family Pharmacy. The microbial growth was seen in
samples from two separate lots (batches). Additional samples and lots of PF MPA are
still under evaluation, as well as other sterile products produced by Main Street.
FDA, in partnership with CDC, is working to identify the exact species of fungus and
bacteria observed in the vials. FDA has received reports of adverse events,
including skin and soft tissue abscesses. To date, FDA is not aware of any cases of
meningitis associated with Main Street’s preservative free methylprednisolone
acetate for injection.

Nephron Pharmaceuticals Corp. EZ Breathe Atomizer: Class 1 Recall - Washer Could
Become Dislodged
A Medical Device Recall was issued due to a manufacturing defect which
could result in the washer ("Plate A") becoming dislodged from the EZ Breathe
Atomizer. If this occurs, users may accidentally swallow the washer or choke on it,
which can lead to serious adverse health consequences or death.
The EZ Breathe Atomizer is a device that is intended to spray liquid
medication in aerosol form into the air that a person will breathe. Devices were
distributed between August 2012 and April 2013.
The EZ Breathe Atomizer is manufactured by Health & Life Co., LTD and sold to
Nephron Pharmaceuticals Corporation. Nephron Pharmaceuticals Corporation distributes
the EZ Breathe Atomizer for sale and use in the Asthmanefrin Starter Kit.
The EZ Breathe Atomizer was also sold by Nephron Pharmaceuticals Corporation as an
individual device in a carton labeled EZ Breathe Atomizer, Model #EZ-100.
Customers should stop using any EZ Breathe Atomizer units
contained in the Asthmanefrin Starter Kits with the affected lot numbers and also
those that were sold individually. Refer to the Recall Notice for a link to the
affected lot and serial numbers.

Lowlite Investments d/b/a Olympia Pharmacy ("Lowlite")
notified the public
of a voluntary multi-state recall of all sterile drug products
compounded by the
pharmacy that have not reached the expiration date listed on the
product. The recall
is being initiated due to concerns associated with prior quality
control procedures
that impacted sterility assurance. In the event a sterile
product is compromised
patients are at risk for serious and possible life threatening
infections.

The recall includes all sterile products that Olympia Pharmacy
supplied to patients
and offices of licensed medical professionals with a use by date
of 09/25/2013 or
earlier. Olympia Pharmacy will be notifying customers by
phone, fax, or mail to
return the products to the pharmacy.

To date, Lowlite has received no reports of injury or illness
associated with the use of the affected products.

Consumers or health care providers with questions regarding this
recall may contact Lowlite by phone at 888-323-7788 or
407-673-2222 from the hours
of 9:00AM- 6:00PM Eastern Daylight Time Monday through
Friday.

Patients who have received any product
furnished by Lowlite and have concerns should contact their healthcare provider.

Magnesium Sulfate: Drug Safety Communication - Recommendation Against Prolonged Use
in Pre-term Labor
FDA is advising health care professionals against using magnesium sulfate
injection for more than 5-7 days to stop pre-term labor in pregnant women.
Administration of magnesium sulfate injection to pregnant women longer than 5-7 days
may lead to low calcium levels and bone problems in the developing baby or fetus,
including thin bones (osteopenia), and fractures. The shortest duration of treatment
that can result in harm to the baby is not known. See the Data Summary in the Drug
Safety Communication for additional information.
This use of the drug is off-label, and is not an FDA-approved use of
the drug. Magnesium sulfate is approved to prevent seizures in preeclampsia, a
condition in which the pregnant woman develops high blood pressure and protein in
the urine, and for control of seizures in eclampsia. Both preeclampsia and eclampsia
are life-threatening complications that can occur during pregnancy. Preeclampsia can
lead to eclampsia, seizures, stroke, multiple organ failure, and death of the woman
and/or baby.
In light of this new safety information about low calcium levels
and bone problems in the developing baby, the following information is being added
to the drug label for Magnesium Sulfate Injection, USP 50%:
* A new Warning stating that continuous administration of magnesium sulfate
injection beyond 5-7 days in pregnancy for the treatment of pre-term labor can
cause low calcium levels and bone changes in the baby.
* A new Teratogenic Effects section conveying the potential harm to developing
babies by changing the Pregnancy Category to D from A. Pregnancy Category D means
there is positive evidence of human fetal risk, but the potential benefits from
using the drug in pregnant women may be acceptable in certain situations despite
its risks.
* A new Labor and Delivery section emphasizing that continuous administration of
magnesium sulfate injection to treat pre-term labor is not approved and that the
safety and efficacy of use for this indication are not established. When used in
pregnant women for conditions other than its approved indication, magnesium
sulfate injection should be administered only by trained obstetrical personnel in
a hospital setting with appropriate obstetrical care facilities.
Pregnant women should discuss with their health care professional the possibility of
going into labor before term and the risks and benefits of any treatments that may
be used.

Magnesium Sulfate Injection by Fresenius Kabi USA: Recall - Glass Particles in Vials
Fresenius Kabi USA notified health professionals of a voluntary recall of
one lot – Lot 6103882 – of Magnesium Sulfate Injection, USP due to the potential
presence of glass particles in the vials. The recalled product is labeled with
Product Code 6450 and packaged as 500mg/mL strength in 50mL glass vials (25 vials
per tray). The product was shipped in the United States between May 30, 2012 and
June 6, 2012 and has an expiration date of October 31, 2014.
The administration of glass particulate, if present in a parenteral drug, can lead
to sequelae of thromboembolism, some life-threatening (such as pulmonary emboli);
phlebitis, mechanical block of the capillaries or arterioles; activation of
platelets; and subsequent generation of microthrombi. Patients with preexisting
condition of trauma or other medical condition that adversely affects the
microvascular blood supply are at an increased risk. Administration of a glass
particulate can also lead to formation of granulomas, a protective local
inflammatory response to the foreign material.
Magnesium sulfate is used as electrolyte replacement therapy in the
treatment of magnesium deficiency, and as an anticonvulsant to prevent and control
seizures in severe toxemia of pregnancy.
All customers who received the recalled vials are being notified
and instructed to return any unused product to their supplier.

Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of
Adverse Reactions Associated with Steroid Injections - Update
[*UPDATE* 05/28/2013] Main Street Family Pharmacy, LLC has announced a voluntary
nationwide recall of all lots of all sterile products compounded by the pharmacy.
The compounded products that are subject to the recall are those with a use by date
on or before November 20, 2013. The recall is being initiated due to seven (7)
reported cases of adverse events in the form of skin abscesses, one of which appears
to be fungal in nature. An investigation into the exact source of the adverse events
is still ongoing.
These products were supplied to the offices of licensed medical professionals and
patients. Sterile products included in this withdrawal were distributed nationwide.

Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of
Adverse Reactions Associated with Steroid Injections
The U.S. Food and Drug Administration is working closely with the Centers
for Disease Control and Prevention and Tennessee Board of Pharmacy to investigate
reports of seven adverse events associated with steroid injections compounded by
Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn. The reports of
adverse events are all from patients who received preservative free
methylprednisolone acetate (80 mg/mL) by injection. To date, the FDA has received
seven reports. Clinical information about these patients is pending; at least one of
these infections appears to be fungal in nature.
An investigation into the exact source of these adverse events is
still ongoing, but these cases are associated with a potentially contaminated
medication. As part of the ongoing investigation, the FDA will continue to work
closely with the CDC and state authorities to thoroughly review the sterile
practices at Main Street.
Out of an abundance of caution, the FDA recommends that health
care providers not administer any products labeled as sterile from Main Street and
quarantine them until further guidance is provided.

Cook Medical, Inc Zilver PTX Drug-Eluting Peripheral Stent: Class 1 Recall -
Complaints of Delivery System Tip Separation
Cook Medical received a small number of complaints that the delivery system
of the device had separated at the tip of the inner catheter. Potential adverse
events that may occur in cases where the inner deliver catheter breakage occurs
include possible surgery to remove the catheter tip, vascular occlusion due to an
unretrieved catheter tip, thrombosis, amputation, possible cardiac arrest, and
death. This recall includes all sizes, diameters and lot numbers prior to April 16,
2013.
The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding,
small metal, mesh tube with the outer surface coated with the drug Paclitaxel that
is implanted in an artery of the thigh. The Paclitaxel coating helps prevents the
artery from narrowing again. The Zilver PTX Drug-Eluting Peripheral Stent acts as a
scaffold to hold open a narrowed artery caused by Peripheral Artery Disease in the
legs and to improve blood flow.
The Zilver PTX Drug-Eluting Peripheral Stent was manufactured from Dec. 1, 2012
through April 16, 2013 and distributed from Dec. 13, 2012 through April 16, 2013.
Cook Medical sent an Urgent Medical Device Recall letter dated
April 24, 2013 to all affect customers. The letter identified the affected products,
description of the problem, and actions to be taken. The letter instructed customers
to stop use, quarantine, and return all affected products for credit to Cook
Medical.

Methotrexate Sodium, USP Injectable Vials by Sandoz US: Recall - Particulate Matter
In Vials
Sandoz is conducting a voluntary nationwide recall to the hospital/user
level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable
product in the US, due to the discovery of particulate matter in vials during
routine quality examination of retention samples at the manufacturer. Parenteral
injection of drug from the affected lots can lead to microembolisation in areas
where the particles lodge. Clinical symptoms are not to be expected from these
microemboli and Sandoz is not aware of any reports of related adverse events.
Methotrexate is an antimetabolite used in the treatment of neoplastic
diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular
juvenile rheumatoid arthritis. The lot numbers and expiration dates of the two
recalled lots are: CL0996 (expiration date 12/2013) and CJ4948 (expiration date
05/2013). These lots were distributed nationally across the US and to a single
foreign country (Poland).
In the event that a patient experiences an adverse reaction or
quality problem involving this product, they should immediately contact their
healthcare professional as well as Sandoz to report the finding. The Sandoz Drug
Information Direct Line is open at 800-525-2492, 24 hours/day, seven days a week.

Abbott Diabetes Care: Class 1 Recall - FreeStyle InsuLinx Blood Glucose Meters -
Risk of Incorrect Test Result
Abbott initiated a voluntary recall of FreeStyle lnsulinx Blood Glucose
Meters in the United States. At extremely high blood glucose levels of 1024 mg/dL
and above, the FreeStyle InsuLinx Blood Glucose Meter will display and store in
memory an incorrect test result that is 1024 mg/dL below the measured result. Blood
glucose levels at 1024 mg/dL and above are very rare. However, if high blood glucose
levels of 1024 mg/dL and above occur, they are a serious health risk that requires
immediate medical attention.
The FreeStyle InsuLinx Blood Glucose Meter measures sugar (glucose) in
blood drawn from the fingertips of people with diabetes to monitor blood sugar
levels. On April 15, 2013, Abbott Diabetes Care sent an Urgent Product Recall letter
to all its affected customers. The FreeStyle InsuLinx Blood Glucose Meters were
distributed from April 18, 2012 through April 1, 2013.
Contact Abbott Diabetes Care Customer Service at 1-866-723-2697 to expedite
return and replacement of your FreeStyle InsuLinx meter at no charge. Replacements
are available, and Abbott will send a meter to you immediately upon request.
Healthcare professionals who have FreeStyle InsuLinx Blood Glucose Monitoring Kits
are advised to immediately discontinue dispensing them to your patients, and to
arrange for product return and replacement, call Abbott Diabetes Care customer
service at 1-866-723-2697.

All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility:
Recall - Lack Of Sterility Assurance
FDA is alerting health care providers of concerns about a lack of sterility
assurance of all sterile drug products made and distributed by NuVision Pharmacy of
Dallas, Texas. The FDA is basing this expanded alert on a recent inspection of the
NuVision Dallas facility, during which FDA investigators observed poor
sterile production practices that raise concerns about a lack of sterility assurance
of the company’s sterile drug products. The agency is not aware of any additional
adverse event reports associated with other sterile products from NuVision.
In April 2013, NuVision recalled Methylcobalamin injection and
lyophilized injection products due to a lack of sterility assurance and concerns
associated with the quality control processes identified during the FDA inspection.
The FDA received adverse event reports of fever, flu-like symptoms, and soreness at
the injection site associated with the Methylcobalamin injection product that was
previously recalled.
For all sterile products from NuVision, the FDA recommends that
health care providers and other health care professionals, including hospital staff,
immediately check their medical supplies for NuVision sterile products, quarantine
those products, and not administer them to patients. Patients who were administered
any sterile drug products produced and distributed by NuVision and who have concerns
should contact their health care provider.

Compounded Prescription Therapies By Pentec Health Inc.: Recall - Lack Of Sterility
Assurance
Pentec Health, Inc. initiated a limited, voluntary recall of in-date
nutritional prescriptions for renal patients due to lack of sterility assurance
associated with one of its laminar flow hoods used in compounding. Pentec Health has
received no reports of injury or illness associated with any of the prescriptions
subject to this recall. However, because patients are at increased risk of infection
in the event a sterile product is compromised, the pharmacy is recalling any unused
product whose beyond-use date has not passed.
These renal therapies were supplied to renal dialysis centers and
directly to patients. Pentec Health is directly notifying each dialysis center and
in-home dialysis patient of the recall. Prescriptions for a total of 163 patients
are included in the scope of this recall. The recall covers renal therapies that
were compounded in this hood on or before May 2, 2013. Sterility tests associated
with the compounding hood involved, as well as testing of finished products made in
the hood, have shown sterility.
Consumers or health care providers with questions regarding this
recall may contact Pentec Health by phone at 800-223-4376, prompt 7
Monday through Friday, between 9:00 am and 8:00 pm EDT.
Patients who have received any prescriptions prepared by Pentec Health and have
concerns should contact their health care provider.

Atriphen dietary supplement (Xymogen brand): Recall - Potential Allergic Reaction
Due to Milk and Soy
The nutraceutical company, Xymogen, (Orlando, FL) and FDA, are notifying
consumers and health professionals of the recall of Atriphen, a product sold for the
support of healthy joint function, because it contains the undeclared allergens, soy
and milk.
Xymogen learned that Atriphen might contain the two allergens,
immediately discontinued sale of the product and had a third-party laboratory test
the product to confirm the presence of the allergens.
People who have an allergy or severe sensitivity to either milk or
soy run the risk of serious or life-threatening allergic reaction if they consume
this product. Although there have been no reported allergic reactions or any adverse
events in connection with the product to date, consumers are urged to return this
product for a full refund.

The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products
The U.S. Food and Drug Administration is alerting health care providers,
hospital supply managers, and pharmacists that the FDA’s preliminary findings of
practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a
lack of sterility assurance for sterile drugs produced at and distributed from this
site. Therefore, these products should not be administered to patients. If a drug
product marketed as sterile has microbial contamination, it potentially places
patients at risk of serious infection.
The FDA has advised the firm that it is in the best interest of public health to
take action to remove all sterile products from the market. The Compounding Shop has
informed the FDA that it is recalling sterile products and is in the process of
notifying customers.
The FDA is basing this warning on a recent inspection of The
Compounding Shop. The investigators observed poor sterile production practices that
raise concerns about a lack of sterility assurance of The Compounding Shop’s sterile
drug products.
Health care providers and hospital staff should immediately check
their medical supplies, quarantine any sterile products from The Compounding Shop,
not administer them to patients, and await further instructions from the company
regarding the recalled products. Patients who have received any product produced by
The Compounding Shop and have concerns should contact their health care provider.